The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of VIR-2218 in Healthy Subjects and Patients With Chronic Hepatitis B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03672188
Recruitment Status : Completed
First Posted : September 14, 2018
Results First Posted : December 13, 2021
Last Update Posted : December 13, 2021
Sponsor:
Collaborator:
Alnylam Pharmaceuticals
Information provided by (Responsible Party):
Vir Biotechnology, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Hepatitis B
Interventions Drug: VIR-2218
Drug: Placebo
Enrollment 82
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A SAD VIR-2218 900 mg Part A: SAD Placebo Part B: MAD VIR-2218 20 mg Part B: MAD VIR-2218 50 mg Part B: MAD VIR-2218 100 mg Part B: MAD VIR-2218 200 mg Part C: MAD VIR-2218 50 mg Part C: MAD 200 mg Part B: MAD Placebo Part C: MAD Placebo
Hide Arm/Group Description

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of placebo administered SC

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection
Period Title: Overall Study
Started 6 6 6 8 6 6 12 3 6 6 3 3 3 6 2
Dosed 6 6 6 7 [1] 6 6 12 3 6 6 3 3 3 6 2
Completed 6 6 5 [2] 5 6 6 12 3 6 6 3 3 2 [3] 6 2
Not Completed 0 0 1 3 0 0 0 0 0 0 0 0 1 0 0
Reason Not Completed
Withdrawal by Subject             0             0             0             3             0             0             0             0             0             0             0             0             0             0             0
Death             0             0             0             0             0             0             0             0             0             0             0             0             1             0             0
Lost to Follow-up             0             0             1             0             0             0             0             0             0             0             0             0             0             0             0
[1]
1 subject was not dosed and therefore not included in any analyses.
[2]
1 Subject could not attend last follow up (Week 12 visit)
[3]
1 non-treatment related SAE of suicide during follow up period
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg Part A: SAD Placebo Part B: MAD VIR-2218 20 mg Part B: MAD VIR-2218 50 mg Part B: MAD VIR-2218 100 mg Part B: MAD VIR-2218 200 mg Part C: MAD VIR-2218 50 mg Part C: MAD VIR-2218 200 mg Part B: MAD Placebo Part C: MAD Placebo Total
Hide Arm/Group Description

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of placebo administered SC

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection

 Total of all reporting groups
Overall Number of Baseline Participants 6 6 6 7 6 6 12 3 6 6 3 3 3 6 2 81
Hide Baseline Analysis Population Description
The Overall Number of Baseline Participants is not consistent with numbers provided in the rows of the Participant Flow module because we enrolled and randomized 8 participants for the Part A 400 mg cohort, but only 7 of these participants were dosed and included for full analysis dataset. We have added a row for dosed participants in the Participant Flow module, to clarify this inconsistency and reflect the number of participants in the analysis dataset.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 7 participants 6 participants 6 participants 12 participants 3 participants 6 participants 6 participants 3 participants 3 participants 3 participants 6 participants 2 participants 81 participants
25  (3) 23.3  (4) 26.7  (3.8) 24.3  (3.7) 28.8  (6.3) 32.5  (9.5) 26.5  (6.7) 40.3  (9.1) 42.5  (10.8) 45.2  (5.5) 55  (4) 35  (9.8) 33.7  (13.1) 44  (7.2) 58.5  (7.8) 33.4  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 7 participants 6 participants 6 participants 12 participants 3 participants 6 participants 6 participants 3 participants 3 participants 3 participants 6 participants 2 participants 81 participants
Female
6
 100.0%
4
  66.7%
3
  50.0%
7
 100.0%
3
  50.0%
3
  50.0%
5
  41.7%
1
  33.3%
1
  16.7%
1
  16.7%
3
 100.0%
2
  66.7%
1
  33.3%
3
  50.0%
1
  50.0%
44
  54.3%
Male
0
   0.0%
2
  33.3%
3
  50.0%
0
   0.0%
3
  50.0%
3
  50.0%
7
  58.3%
2
  66.7%
5
  83.3%
5
  83.3%
0
   0.0%
1
  33.3%
2
  66.7%
3
  50.0%
1
  50.0%
37
  45.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 7 participants 6 participants 6 participants 12 participants 3 participants 6 participants 6 participants 3 participants 3 participants 3 participants 6 participants 2 participants 81 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   2.5%
Not Hispanic or Latino
6
 100.0%
6
 100.0%
6
 100.0%
7
 100.0%
6
 100.0%
5
  83.3%
11
  91.7%
3
 100.0%
6
 100.0%
6
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
6
 100.0%
2
 100.0%
79
  97.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 7 participants 6 participants 6 participants 12 participants 3 participants 6 participants 6 participants 3 participants 3 participants 3 participants 6 participants 2 participants 81 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  33.3%
3
  50.0%
0
   0.0%
0
   0.0%
2
  33.3%
1
  16.7%
1
   8.3%
3
 100.0%
5
  83.3%
5
  83.3%
3
 100.0%
3
 100.0%
3
 100.0%
6
 100.0%
2
 100.0%
39
  48.1%
Native Hawaiian or Other Pacific Islander
1
  16.7%
1
  16.7%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
2
  16.7%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6
   7.4%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
2
  33.3%
2
  33.3%
5
  83.3%
5
  71.4%
3
  50.0%
3
  50.0%
8
  66.7%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
29
  35.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  16.7%
0
   0.0%
1
  16.7%
1
  14.3%
1
  16.7%
2
  33.3%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7
   8.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
New Zealand Number Analyzed 6 participants 6 participants 6 participants 7 participants 6 participants 6 participants 12 participants 3 participants 6 participants 6 participants 3 participants 3 participants 3 participants 6 participants 2 participants 81 participants
6 6 6 7 6 6 12 0 2 1 0 1 0 0 1 54
South Korea Number Analyzed 6 participants 6 participants 6 participants 7 participants 6 participants 6 participants 12 participants 3 participants 6 participants 6 participants 3 participants 3 participants 3 participants 6 participants 2 participants 81 participants
0 0 0 0 0 0 0 1 1 2 2 1 0 1 0 8
Hong Kong Number Analyzed 6 participants 6 participants 6 participants 7 participants 6 participants 6 participants 12 participants 3 participants 6 participants 6 participants 3 participants 3 participants 3 participants 6 participants 2 participants 81 participants
0 0 0 0 0 0 0 1 3 0 0 1 1 2 0 8
Australia Number Analyzed 6 participants 6 participants 6 participants 7 participants 6 participants 6 participants 12 participants 3 participants 6 participants 6 participants 3 participants 3 participants 3 participants 6 participants 2 participants 81 participants
0 0 0 0 0 0 0 0 0 2 0 0 2 0 0 4
Thailand Number Analyzed 6 participants 6 participants 6 participants 7 participants 6 participants 6 participants 12 participants 3 participants 6 participants 6 participants 3 participants 3 participants 3 participants 6 participants 2 participants 81 participants
0 0 0 0 0 0 0 1 0 1 1 0 0 3 1 7
Hepatitis B Surface Antigen Levels (IU/mL)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  IU/mL
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 6 participants 6 participants 3 participants 3 participants 3 participants 6 participants 2 participants 32 participants
2372.227  (1168.940) 3872.625  (5678.292) 4009.863  (5239.703) 2374.423  (2078.034) 3488.037  (2454.215) 12640.983  (10495.983) 4819.127  (6348.594) 1886.045  (1223.655) 4456.52  (5657.74)
[1]
Measure Description: HBsAg Levels seen across dose levels for Chronic Hepatitis B Subjects.
[2]
Measure Analysis Population Description: HBsAg levels would not be seen in Healthy subjects population, therefore 0 subjects were analyzed in corresponding dose levels.
Alanine Aminotransferase Levels   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 6 participants 6 participants 3 participants 3 participants 3 participants 6 participants 2 participants 32 participants
15.3  (4.6) 23.5  (14.9) 14.3  (5.0) 10.0  (4.0) 27.7  (18.6) 26.0  (17.7) 21.8  (17.6) 26.5  (10.6) 20.25  (13.08)
[1]
Measure Description: Alanine Aminotransferase Levels in Chronic Hepatitis B Subjects
[2]
Measure Analysis Population Description: Alanine Aminotransferase Levels were not analyzed in Healthy subjects population.
1.Primary Outcome
Title Incidence of Adverse Events (AEs)
Hide Description Number of Subjects with Adverse Events as assessed by CTCAE v5.0. In our planned analysis for this outcome measure, incidence is defined as the number of participants with treatment emergent AEs (TEAEs) in relation to the total number of participants in the cohort.
Time Frame Up to 364 days
Hide Outcome Measure Data
Hide Analysis Population Description
The Overall Number of Participants Analyzed is not consistent with numbers provided in the rows of the Participant Flow module because we enrolled and randomized 8 participants for the Part A 400 mg cohort, but only 7 of these participants were dosed and included for full analysis dataset. We have added a row for dosed participants in the Participant Flow module, to clarify this inconsistency and reflect the number of participants in the analysis dataset.
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2219 900 mg Part A: SAD Placebo Part B: MAD VIR-2218 20 mg Part B: MAD VIR-2218 50 mg Part B: MAD VIR-2218 100 mg Part B: MAD VIR-2218 200 mg Part C: MAD VIR-2218 50 mg Part C: MAD VIR-2218 200 mg Part B: MAD Placebo Part C: MAD Placebo
Hide Arm/Group Description:

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of placebo administered SC

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection
Overall Number of Participants Analyzed 6 6 6 7 6 6 12 3 6 6 3 3 3 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
4
  66.7%
3
  50.0%
4
  66.7%
5
  71.4%
3
  50.0%
3
  50.0%
6
  50.0%
0
   0.0%
2
  33.3%
5
  83.3%
2
  66.7%
2
  66.7%
2
  66.7%
1
  16.7%
1
  50.0%
2.Primary Outcome
Title Clinical Assessments Including But Not Limited to Laboratory Test Results
Hide Description Number of participants with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
Time Frame Up to 336 days
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants analyzed is inclusive of clinically significant Vital Signs, ECGs, and Lab Findings. The Overall Number of Participants Analyzed is not consistent with numbers provided in the rows of the Participant Flow module. This inconsistency has been explained in the Analysis Population Description in our First Primary Outcome Measure as well.
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg Part A: SAD Placebo Part B: MAD VIR-2218 20 mg Part B: MAD VIR-2218 50 mg Part B: MAD VIR-2218 100 mg Part B: MAD VIR-2218 200 mg Part C: MAD VIR-2218 50 mg Part C: MAD VIR-2218 200 mg Part B: MAD Placebo Part C: MAD Placebo
Hide Arm/Group Description:

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of placebo administered SC

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection
Overall Number of Participants Analyzed 6 6 6 7 6 6 12 3 6 6 3 3 3 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
CTCAE v5.0 Lab Grade 0
1
  16.7%
1
  16.7%
1
  16.7%
1
  14.3%
1
  16.7%
0
   0.0%
1
   8.3%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
CTCAE v5.0 Lab Grade 1
3
  50.0%
3
  50.0%
3
  50.0%
4
  57.1%
4
  66.7%
3
  50.0%
7
  58.3%
2
  66.7%
4
  66.7%
5
  83.3%
3
 100.0%
3
 100.0%
3
 100.0%
3
  50.0%
2
 100.0%
CTCAE v5.0 Lab Grade 2
1
  16.7%
2
  33.3%
1
  16.7%
1
  14.3%
1
  16.7%
3
  50.0%
3
  25.0%
0
   0.0%
2
  33.3%
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
2
  33.3%
0
   0.0%
CTCAE v5.0 Lab Grade 3
1
  16.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   8.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
CTCAE v5.0 Lab Grade 4
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Clinically Significant Vital Signs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Clinically Significant ECG
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Maximum Plasma Concentration (ng/mL)
Hide Description VIR-2218 and metabolite Maximum Concentration in Plasma
Time Frame Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg Part B/C: MAD VIR-2218 20 mg Part B/C: MAD VIR-2218 50 mg Part B/C: MAD VIR-2218 100 mg Parts B/C: MAD VIR-2218 200 mg
Hide Arm/Group Description:

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection
Overall Number of Participants Analyzed 6 5 6 6 6 6 3 9 6 6
Mean (Standard Deviation)
Unit of Measure: ng/mL
VIR-2218 Cmax (Day 1) Number Analyzed 6 participants 5 participants 6 participants 6 participants 6 participants 6 participants 2 participants 7 participants 6 participants 6 participants
155  (65.3) 355  (117) 711  (207) 2110  (722) 1830  (615) 5010  (630) 73.5 [1]   (NA) 118  (61.2) 235  (79.0) 826  (336)
AS (N-1)3' VIR-2218 Cmax (Day 1) Number Analyzed 6 participants 2 participants 6 participants 6 participants 6 participants 6 participants 3 participants 9 participants 6 participants 2 participants
NA [2]   (NA) 40.5 [3]   (NA) 62.4  (17.6) 259  (114) 177  (99.2) 514  (106) NA [2]   (NA) NA [2]   (NA) NA [2]   (NA) 66.1 [4]   (NA)
VIR-2218 Cmax (Day 29) Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 8 participants 6 participants 6 participants
51.8  (21.1) 115  (38.2) 256  (167) 807  (374)
AS (N-1)3' VIR-2218 Cmax (Day 29) Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 9 participants 1 participants 3 participants
NA [2]   (NA) NA [2]   (NA) NA [5]   (NA) 75.1  (27.2)
[1]
SD is not reported when n<3. Not calculable; measurable in 2/3 subjects.
[2]
Values were below the limit of quantification
[3]
SD is not reported when n<3
[4]
SD is not reported when n<3. Not calculable; measurable in 2/6 subjects.
[5]
Mean not calculable if n=1
4.Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (h)
Hide Description VIR-2218 and metabolite time of Cmax in Plasma: Median (Inter-Quartile Range Q1-Q3)
Time Frame Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg Part B/C: MAD VIR-2218 20 mg Part B/C: MAD VIR-2218 50 mg Part B/C: MAD VIR-2218 100 mg Part B/C: MAD VIR-2218 200 mg
Hide Arm/Group Description:

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection
Overall Number of Participants Analyzed 6 5 6 6 6 6 3 9 6 6
Median (Inter-Quartile Range)
Unit of Measure: h
VIR-2218 Tmax Day 1 Number Analyzed 6 participants 5 participants 6 participants 6 participants 6 participants 6 participants 3 participants 9 participants 6 participants 6 participants
4.25
(1.17 to 4.25)
4.32
(4.25 to 6.17)
5.21
(4.25 to 6.18)
7.21
(4.25 to 8.25)
7.21
(6.17 to 10.2)
4.25
(4.25 to 8.25)
4.00
(4.00 to 8.02)
7.63
(4.00 to 7.93)
2.48
(1.00 to 7.97)
5.98
(3.98 to 8.00)
AS(N-1)3' VIR-2218 Tmax Day 1 Number Analyzed 6 participants 3 participants 6 participants 6 participants 6 participants 6 participants 3 participants 9 participants 6 participants 6 participants
NA [1] 
(NA to NA)
6.17
(4.25 to 6.17)
6.17
(4.25 to 6.18)
9.21
(4.25 to 10.2)
10.2
(8.25 to 10.2)
8.25
(4.25 to 10.2)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
8.00
(7.97 to 8.00)
VIR-2218 Tmax Day 29 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 9 participants 6 participants 6 participants
3.95
(0.92 to 4.00)
4.00
(4.00 to 7.98)
8.00
(4.00 to 8.00)
3.99
(2.00 to 8.00)
AS (N-1)3' VIR-2218 Tmax Day 29 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 9 participants 2 participants 6 participants
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
6.00
(4.00 to 8.00)
5.99
(4.00 to 8.00)
[1]
Values were below the limit of quantification
5.Secondary Outcome
Title Area Under the Plasma Concentration Versus Time Curve (ng*h/mL)
Hide Description VIR-2218 and metabolite Area under the curve from time 0 to last measurable Time
Time Frame Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1; Part B/C: predose on Day 1 and at 1h, 2h, 4h, 8h, 24h postdose, Week 1, predose on Week 4 and at 1h, 2h, 4h, 8h, 24h postdose, and Week 5
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg Part B/C: MAD VIR-2218 20mg Part B/C: MAD VIR-2218 50 mg Part B/C: MAD VIR-2218 100 mg Part B/C: MAD VIR-2218 200 mg
Hide Arm/Group Description:

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection
Overall Number of Participants Analyzed 6 5 6 6 6 6 3 9 6 6
Mean (Standard Deviation)
Unit of Measure: h*ng/mL
VIR-2218 AUClast (Day 1) Number Analyzed 6 participants 5 participants 6 participants 6 participants 6 participants 6 participants 3 participants 9 participants 6 participants 6 participants
1270  (270) 3740  (1190) 6630  (1160) 23500  (2700) 27900  (7540) 58800  (9070) 360  (199) 1000  (285) 2700  (943) 9570  (2410)
AS(N-1) 3' VIR-2218 AUClast (Day 1) Number Analyzed 6 participants 3 participants 6 participants 6 participants 6 participants 6 participants 3 participants 9 participants 6 participants 6 participants
NA [1]   (NA) 208  (190) 481  (149) 2530  (613) 2680  (1460) 6430  (1500) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) 482  (199)
VIR-2218 AUClast (Day 29) Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 9 participants 6 participants 6 participants
339  (171) 910  (326) 2550  (638) 9580  (3240)
AS(N-1) 3' VIR-2218AUClast (Day 29) Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 3 participants 9 participants 2 participants 6 participants
NA [1]   (NA) NA [1]   (NA) 174 [2]   (NA) 393  (230)
[1]
Values were below the Limit of quantification
[2]
SD not calculated when n < 3
6.Secondary Outcome
Title Apparent Terminal Elimination Half-life (h)
Hide Description VIR-2218 Apparent Elimination Half-life t1/2 in Plasma: Median (Inter-Quartile Range Q1-Q3)
Time Frame Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose and Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg
Hide Arm/Group Description:

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection
Overall Number of Participants Analyzed 5 4 5 6 6 6
Median (Inter-Quartile Range)
Unit of Measure: h
2.45
(2.35 to 3.26)
3.64
(3.49 to 4.95)
4.38
(4.22 to 6.11)
3.54
(2.49 to 5.51)
5.28
(5.12 to 5.62)
4.55
(3.25 to 4.69)
7.Secondary Outcome
Title Apparent Plasma Clearance (L/h)
Hide Description VIR-2218 CL/F Apparent plasma clearance
Time Frame Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg
Hide Arm/Group Description:

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection
Overall Number of Participants Analyzed 5 4 5 6 6 6
Mean (Standard Deviation)
Unit of Measure: L/h
34.0  (2.54) 21.8  (4.27) 30.8  (4.51) 16.8  (1.76) 21.9  (6.91) 15.3  (2.08)
8.Secondary Outcome
Title Apparent Volume of Distribution (L)
Hide Description VIR-2218 VZ/F apparent volume of distribution
Time Frame Part A: predose on Day 1 and at 30 min, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 24h, 48h postdose, and Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg
Hide Arm/Group Description:

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection
Overall Number of Participants Analyzed 5 4 5 6 6 6
Mean (Standard Deviation)
Unit of Measure: L
155  (69.7) 132  (40.7) 223  (76.0) 104  (62.6) 176  (60.8) 92.9  (24.6)
9.Secondary Outcome
Title Urine %fe 0-24h
Hide Description VIR-2218 and metabolite: Fraction excreted in the urine from time 0 to 24 h. Pooled Urine PK samples was collected at pre-specified intervals in the single ascending dose study of VIR-2218. Therefore, the following PK parameter, fraction excreted in the urine ( %fe 0-24h ) was only calculated in healthy subjects who participated in Part A of the study. This parameter was not listed as a secondary endpoint for parts B/C in the submitted protocol, and as such was not reported in this secondary outcome measures.
Time Frame Pooled urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A SAD: VIR-2218 50 mg Part A SAD: VIR-2218 100 mg Part A SAD: VIR-2218 200 mg Part A SAD: VIR-2218 400 mg Part A SAD: VIR-2218 600 mg Part A SAD: VIR-2218 900 mg
Hide Arm/Group Description:

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection
Overall Number of Participants Analyzed 6 5 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: % excreted in the urine from time 0-24h
VIR-2218 fe 0-24 16.9  (3.19) 21.7  (6.22) 23.2  (4.34) 29.5  (5.72) 32.3  (11.7) 47.6  (8.59)
AS(N-1)3' VIR-2218 fe 0-24 1.94  (0.480) 4.16  (2.28) 3.31  (0.656) 4.99  (0.740) 4.12  (2.31) 6.96  (1.47)
10.Secondary Outcome
Title Apparent Renal Clearance (CLR/F)
Hide Description VIR-2218 Apparent renal clearance from 0 to 24 h. Pooled Urine PK samples was collected at pre-specified intervals in the single ascending dose study of VIR-2218. Therefore, the following PK parameter, apparent renal clearance (CLR/F) was only calculated in healthy subjects who participated in Part A of the study. This parameter was not listed as a secondary endpoint for parts B/C in the submitted protocol, and as such was not reported in this secondary outcome measures.
Time Frame Pooled Urine was collected at time interval D1 (0-4 hrs) (4-8 hrs) (8-12 hrs) and (12-24 hrs)
Hide Outcome Measure Data
Hide Analysis Population Description
The PK Analysis Set includes all randomized subjects who had at least 1 dose of VIR-2218 and 1 post-baseline PK parameter
Arm/Group Title Part A: SAD VIR-2218 50 mg Part A: SAD VIR-2218 100 mg Part A: SAD VIR-2218 200 mg Part A: SAD VIR-2218 400 mg Part A: SAD VIR-2218 600 mg Part A: SAD VIR-2218 900 mg
Hide Arm/Group Description:

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection
Overall Number of Participants Analyzed 5 4 5 6 6 6
Mean (Standard Deviation)
Unit of Measure: L/h
5.87  (0.728) 5.22  (1.27) 7.00  (0.659) 5.13  (0.850) 7.22  (1.480) 7.47  (1.340)
11.Secondary Outcome
Title Maximum Reduction of Serum HBsAg From Baseline
Hide Description Maximum reduction of serum HBsAg from Day 1 until Week 16.
Time Frame Up to 112 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Hide Arm/Group Description:

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection
Overall Number of Participants Analyzed 3 6 6 3 3 3 6 2
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-1.031  (0.574) -1.230  (0.702) -1.504  (0.540) -1.653  (0.154) -1.161  (0.350) -1.568  (0.636) -0.098  (0.047) -0.068  (0.01)
12.Secondary Outcome
Title Number of Subjects With Serum HBsAg Loss at Any Time Point
Hide Description Serum HBsAg loss is defined as quantitative HBsAg < 0.05 IU/mL at two or more consecutive measurements
Time Frame Up to 336 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Hide Arm/Group Description:

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection
Overall Number of Participants Analyzed 3 6 6 3 3 3 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Number of Subjects With Sustained Serum HBsAg Loss for >/= 6 Months
Hide Description Serum HBsAg loss is defined as quantitative HBsAg < 0.05 IU/mL at two or more consecutive measurements
Time Frame Up to 336 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Hide Arm/Group Description:

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection
Overall Number of Participants Analyzed 3 6 6 3 3 3 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Number of Subjects With Anti-HBs Seroconversion at Any Timepoint
Hide Description Anti-HBs seroconversion is defined as anti-HBs positivity at two or more consecutive measurements
Time Frame Up to 336 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Hide Arm/Group Description:

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection
Overall Number of Participants Analyzed 3 6 6 3 3 3 6 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
15.Secondary Outcome
Title Number of Subjects With HBeAg Loss and/or Anti-HBe Seroconversion at Any Timepoint
Hide Description HBeAg loss is defined as quantitative HBeAg < 0.11 IU/mL at two or more consecutive measurements. anti-HBe seroconversion is defined as anti-HBe positivity at two or more consecutive measurements
Time Frame Up to 336 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part C MAD: Placebo
Hide Arm/Group Description:

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection
Overall Number of Participants Analyzed 3 3 2
Measure Type: Count of Participants
Unit of Measure: Participants
Number of Subjects with HBeAg Loss
0
   0.0%
1
  33.3%
0
   0.0%
Number of Subjects with anti-HBe seroconversion
0
   0.0%
1
  33.3%
0
   0.0%
Time Frame Up to 364 days after first dose with VIR-2218 or placebo
Adverse Event Reporting Description The Total Number of Participants at Risk - All Cause Mortality, Serious Adverse Events, and Other (Not Including Adverse Events) tables - is not consistent with numbers provided in the rows of the Participant Flow module. This inconsistency has been explained in the Baseline Analysis Population Description.
 
Arm/Group Title Part A SAD: VIR-2218 50 mg Part A SAD: VIR-2218 100 mg Part A SAD: VIR-2218 200 mg Part A SAD: VIR-2218 400 mg Part A SAD: VIR-2218 600 mg Part A SAD: VIR-2218 900 mg Part A SAD: Placebo Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Hide Arm/Group Description

Healthy subjects received a single dose of VIR-2218 of 50 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 100 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 200 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 400 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 600 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of VIR-2218 of 900 mg administered SC

VIR-2218: VIR-2218 given by subcutaneous injection

Healthy subjects received a single dose of placebo administered SC

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 20 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 100 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 50 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of 200 mg VIR-2218 administered 4 weeks apart.

VIR-2218: VIR-2218 given by subcutaneous injection

Chronic HBV, HBeAg negative, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection

Chronic HBV, HBeAg positive, subjects received 2 SC doses of placebo administered 4 weeks apart.

Placebo: Sterile normal saline (0.9% NaCl) given by subcutaneous injection
All-Cause Mortality
Part A SAD: VIR-2218 50 mg Part A SAD: VIR-2218 100 mg Part A SAD: VIR-2218 200 mg Part A SAD: VIR-2218 400 mg Part A SAD: VIR-2218 600 mg Part A SAD: VIR-2218 900 mg Part A SAD: Placebo Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/7 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/12 (0.00%)   0/3 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   1/3 (33.33%)   0/6 (0.00%)   0/2 (0.00%) 
Hide Serious Adverse Events
Part A SAD: VIR-2218 50 mg Part A SAD: VIR-2218 100 mg Part A SAD: VIR-2218 200 mg Part A SAD: VIR-2218 400 mg Part A SAD: VIR-2218 600 mg Part A SAD: VIR-2218 900 mg Part A SAD: Placebo Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/7 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/12 (0.00%)   0/3 (0.00%)   0/6 (0.00%)   1/6 (16.67%)   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/6 (0.00%)   0/2 (0.00%) 
Nervous system disorders                               
Headache †  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part A SAD: VIR-2218 50 mg Part A SAD: VIR-2218 100 mg Part A SAD: VIR-2218 200 mg Part A SAD: VIR-2218 400 mg Part A SAD: VIR-2218 600 mg Part A SAD: VIR-2218 900 mg Part A SAD: Placebo Part B MAD: VIR-2218 20 mg Part B MAD: VIR-2218 50 mg Part B MAD: VIR-2218 100 mg Part B MAD: VIR-2218 200 mg Part C MAD: VIR-2218 50 mg Part C MAD: VIR-2218 200 mg Part B MAD: Placebo Part C MAD: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/6 (66.67%)   3/6 (50.00%)   4/6 (66.67%)   5/7 (71.43%)   3/6 (50.00%)   3/6 (50.00%)   6/12 (50.00%)   0/3 (0.00%)   2/6 (33.33%)   5/6 (83.33%)   2/3 (66.67%)   2/3 (66.67%)   2/3 (66.67%)   1/6 (16.67%)   1/2 (50.00%) 
Cardiac disorders                               
Palpitations †  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Gastrointestinal disorders                               
Abdominal discomfort *  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Abdominal pain *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Abdominal pain upper *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Constipation *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Nausea *  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Paraesthesia oral *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Toothache *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Vomiting *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
General disorders                               
Catheter site pain *  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Fatigue *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Influenza like illness *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%) 
Injection site bruising *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Injection site discomfort *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Injection site pain *  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%)  1/6 (16.67%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Night sweats *  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Pyrexia *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Infections and infestations                               
Gastroenteritis *  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Influenza *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Respiratory tract infection *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Upper respiratory tract infection *  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  2/12 (16.67%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Viral infection *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Viral upper respiratory tract *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Injury, poisoning and procedural complications                               
Contusion *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Eye contusion *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Limb injury *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Muscle strain *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Investigations                               
Cardiac murmur *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Metabolism and nutrition disorders                               
Dehydration *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Hypophosphataemia *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders                               
Medial tibial stress syndrome *  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Myalgia *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%) 
Neck pain *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Nervous system disorders                               
Dizziness *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Headache *  1/6 (16.67%)  3/6 (50.00%)  2/6 (33.33%)  2/7 (28.57%)  0/6 (0.00%)  1/6 (16.67%)  2/12 (16.67%)  0/3 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%) 
Hypoaesthesia *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Lethargy *  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Renal and urinary disorders                               
Urinary tract infection *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders                               
Cough *  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Dry throat *  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Epistaxis †  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Oropharyngeal pain *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/12 (8.33%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Rhinorrhoea *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/6 (0.00%)  0/2 (0.00%) 
Sneezing *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders                               
Dermatitis contact *  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%)  0/6 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Rash *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Urticaria *  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/12 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
†
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Investigators may discuss or publish results after:

  • the study results in their entirety have been publicly disclosed by or with the consent of the Sponsor OR study has been completed at all investigative sites for at least 2 years
  • provision of publication up to 60 days before planned submission to allow Sponsor to remove confidential information or identify Sponsor intellectual property

Publication may be delayed as applicable, up to 120 days for Sponsor to file patent application(s)

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Inquiry
Organization: Vir Biotechnology, Inc.
Phone: 415-654-5281
EMail: clinicaltrials@vir.bio
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Vir Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT03672188    
Other Study ID Numbers: VIR-2218-1001
First Submitted: September 11, 2018
First Posted: September 14, 2018
Results First Submitted: October 20, 2021
Results First Posted: December 13, 2021
Last Update Posted: December 13, 2021