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Study of ARO-HBV in Normal Adult Volunteers and Patients With Hepatitis B Virus (HBV)

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: NCT03365947
Recruitment Status : Completed
First Posted : December 8, 2017
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of ARO-HBV in healthy adult volunteers and participants with hepatitis B virus (HBV).

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: ARO-HBV Injection Other: Sterile Normal Saline (0.9% NaCl) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Single Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Effects of ARO-HBV in Normal Adult Volunteers and Multiple Escalating Doses Evaluating Safety, Tolerability and Pharmacodynamic Effects in HBV Patients
Actual Study Start Date : March 27, 2018
Actual Primary Completion Date : April 23, 2020
Actual Study Completion Date : April 23, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ARO-HBV Injection Drug: ARO-HBV Injection
Single or multiple doses of ARO-HBV Injection by subcutaneous (sc) injection
Placebo Comparator: Placebo Other: Sterile Normal Saline (0.9% NaCl)
Calculated volume to match active comparator


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) Possibly or Probably Related to Treatment [ Time Frame: Up to 203 days ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of ARO-HBV: Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Part A (single-ascending dose [SAD] phase) only: up to 48 hours post-dose ]
  2. PK of ARO-HBV: Time to Maximum Plasma Concentration (Tmax) [ Time Frame: Part A (SAD phase) only: up to 48 hours post-dose ]
  3. PK of ARO-HBV: Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC0-24) [ Time Frame: Part A (SAD phase) only: up to 48 hours post-dose ]
  4. PK of ARO-HBV: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUCinf) [ Time Frame: Part A (SAD phase) only: up to 48 hours post-dose ]
  5. PK of ARO-HBV: Terminal Elimination Half-Life (t½) [ Time Frame: Part A (SAD phase) only: up to 48 hours post-dose ]
  6. Reduction of HBV Surface Antigen (HBsAg) from Day 1 Pre-Dose Baseline to Post-Dose Nadir in Participants Chronically Infected With HBV [ Time Frame: Part B (multiple-ascending dose [MAD] phase) only: up to 113 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Parts A & B:

  • Women of childbearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use contraception.
  • Willing to provide written informed consent and comply with study requirements

Additional Inclusion Criteria for Part B:

  • Diagnosis of chronic HBV infection
  • HbsAg at screening > or = 50 IU/mL
  • Liver Elastography score < or = 10.5

Exclusion Criteria:

  • Clinically significant health concerns (with the exception of HBV for Patients in Part B)
  • Abnormal for any clinical safety laboratory result considered clinically significant
  • Regular use of alcohol within 1 month prior to screening
  • Recent use of illicit drugs
  • Use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study

NOTE: additional inclusion/exclusion criteria may apply, per protocol

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365947


Locations
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Australia, New South Wales
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
St. Vincent's Hospital
Melbourne, Victoria, Australia, 3065
Australia, Western Australia
Linear Research
Nedlands, Western Australia, Australia, 6009
Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
New Zealand
Auckland Clinical Studies Limited
Grafton, Auckland, New Zealand, 1010
Middlemore Clinical Trials
Papatoetoe, Auckland, New Zealand, 2025
Sponsors and Collaborators
Arrowhead Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03365947    
Other Study ID Numbers: AROHBV1001
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections