Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT04415671
• Recruitment Status: Completed
• First Posted: June 4, 2020
• Last Update Posted: May 6, 2022
• Sponsor: AdAlta Limited
• Information provided by (Responsible Party): AdAlta Limited

Tracking Information

• First Submitted Date: May 27, 2020
• First Posted Date: June 4, 2020
• Last Update Posted Date: May 6, 2022
• Actual Study Start Date: June 19, 2020
• Actual Primary Completion Date: October 21, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 17, 2021): Safety and Tolerability as assessed by the number of abnormal laboratory values and/or adverse events that are related to treatment [ Time Frame: SAD Part A- 28 days. MAD Part B - 57 days ]
• Original Primary Outcome Measures (submitted: May 31, 2020): Safety and Tolerability as assessed by the number of abnormal laboratory values and/or adverse events that are related to treatment [ Time Frame: SAD Part A & B - 28 days. MAD Part C - 50 days ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy Volunteers
• Official Title: A Phase 1, Dose-escalating Study of the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of AD-214 When Administered Intravenously to Healthy Volunteers
• Brief Summary: This is a first in human (FIH), multi-center, dose escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AD-214 when administered to healthy volunteers (HVs). The study in HVs will be a randomized, double blind, and placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) (Part B) study.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

SAD Part A in HVs- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) MAD Part B in HVs- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose: Treatment

• Condition: Interstitial Lung Disease

Intervention

• Biological: AD-214
  AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis.
• Other: Placebo
  Placebo

Study Arms

• Experimental: Part A- AD-214 SAD in Healthy Volunteers
  Intervention: Biological: AD-214
• Placebo Comparator: Part A-Placebo SAD in Healthy Volunteers
  Intervention: Other: Placebo
• Experimental: Part B-AD-214 MAD in Healthy Volunteers
  Intervention: Biological: AD-214
• Placebo Comparator: Part B-Placebo MAD in Healthy Volunteers
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 14, 2021): 50
• Original Estimated Enrollment (submitted: May 31, 2020): 94
• Actual Study Completion Date: February 8, 2022
• Actual Primary Completion Date: October 21, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Must provide signed informed consent prior to study entry and agree to adhere to all study protocol requirements.
2. Maximum weight of 100 kg at the time of consent and body mass index (BMI) >18 and < 30 kg/m2 (inclusive)
3. Must agree to abstain from alcohol intake from 48 hours before first study drug administration through to final study visit
4. Must agree to abstain from smoking from 48 hours before first study drug administration through to final study visit
5. Must have a negative urine drug screen and cotinine test, and alcohol breath test at Screening and on Day -1 (admission).
6. Must agree to use highly effective, double barrier contraception (both male and female partners) at least 30 days prior to dosing on day 1, during the study AND for 90 days following completion of dosing
7. Male participants must refrain from sperm donation from start of study and for 90 days after last dose of AD-214
8. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1.
9. Participants must be in good general health, with no significant medical history, and no clinically significant abnormalities on physical examination at Screening, and/or before administration of the initial dose of study drug.
10. Participants must have clinical laboratory values within normal range or < 1.5 x upper limit of normal (ULN) as specified by the testing laboratory at Screening.

Exclusion Criteria:

1. Received any Investigational Medicinal Product (IMP) within 30 days (4 months if the previous drug was a new chemical entity) or 5 half-lives prior to Screening
2. Received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the investigational product.
3. Received blood products within 1 month prior to Screening.
4. Blood donation or significant blood loss (> 450 mL) within 60 days prior to the first administration of investigational product
5. Plasma donation within 7 days prior to the first administration of investigational product.
6. A bleeding disorder diagnosed by a doctor or significant bruising or bleeding difficulties with blood draws.
7. Known history of Human Immunodeficiency Virus (HIV) or HIV antibody positive.
8. Hepatitis B surface Antigen (HBsAg) positive or Hepatitis B Virus (HBV) polymerase chain reaction (PCR) positivity. Hepatitis C Virus (HCV) antibody positive or HCV PCR positivity.
9. Any clinically significant abnormality at Screening determined by medical history, physical examination, blood chemistry, hematology, coagulation, urinalysis and 12-lead electrocardiogram (ECG).
10. A history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory (apart from ILD), endocrine, oncological, immunodeficiency, neurological, metabolic, hematological, autoimmune or social or psychiatric condition which in the investigator's opinion may interfere with the study objectives, may put the participant at risk or may make the participant unsuitable for participation in the study.
11. Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant.
12. History or presence of alcohol or drug abuse
13. Females who are pregnant or lactating.
14. Use of any prescription or over the counter medication (with the exception of paracetamol and contraceptives) within 7 days of first study drug administration.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT04415671
• Other Study ID Numbers: ADA-AD-214-1A
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: AdAlta Limited
• Original Responsible Party: Same as current
• Current Study Sponsor: AdAlta Limited
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: AdAlta Limited
• Verification Date: May 2022