Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.

February 22, 2024 updated by: Arbutus Biopharma Corporation

A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Dose Study Evaluating the Safety, Tolerability, PK and PD of AB-101, an Oral PD-L1 Inhibitor, in Healthy Subjects and Subjects With Chronic HBV Infection.

This three-part, Phase 1 protocol will be the first clinical study of AB-101. Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-101 in healthy adult subjects.

Part 3 will be a Phase 1b dose-ranging assessment of AB-101 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

164

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • New Zealand
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
        • Recruiting
        • New Zealand Clinical Research Auckland
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: Part 1 and 2 (Healthy Volunteers)

  • Male between ages 18-50 years
  • Willing and able to provide informed consent

Willing to follow protocol-specified contraception requirement

Inclusion Criteria: Part 3 (CHB Subjects)

  • Male or female subjects between the ages of 18-60 years
  • Willing to provide informed consent
  • Chronic HBV infection for at least 6 months
  • Willing to follow protocol-specified contraception requirement

Exclusion Criteria: Part 1 and 2 (Healthy Volunteers)

Key Exclusion Criteria:

  • Clinically significant lab abnormalities
  • A history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, cardiovascular, autoimmune or other immune-mediated disease.
  • HIV or Hep C positive
  • Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.

Exclusion Criteria: Part 3 (CHB Subjects)

  • Have extensive fibrosis or cirrhosis of the liver
  • Have or had liver cancer (hepatocellular carcinoma)
  • Have a history or current autoimmune disease or has been on immunosuppressive medications within 6 months of the start of the study
  • Females who breastfeeding, pregnant or who wish to become pregnant during the study
  • Known chronic or severe infection or recent significant exposure to infections such as tuberculosis or endemic mycosis, untreated latent infections like tuberculosis, or a positive or indeterminate QuantiFERON test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1
Drug: AB-101
AB-101 is an oral small molecule PD-L1 checkpoint inhibitor being developed for the treatment of chronic infection with HBV in combination with other agents.
Drug: Placebo
A placebo is any treatment that has no active properties, such as a sugar pill. We will use matching placebo for this study.
Experimental: Part 2
Drug: AB-101
AB-101 is an oral small molecule PD-L1 checkpoint inhibitor being developed for the treatment of chronic infection with HBV in combination with other agents.
Drug: Placebo
A placebo is any treatment that has no active properties, such as a sugar pill. We will use matching placebo for this study.
Experimental: Part 3
Drug: AB-101
AB-101 is an oral small molecule PD-L1 checkpoint inhibitor being developed for the treatment of chronic infection with HBV in combination with other agents.
Drug: Placebo
A placebo is any treatment that has no active properties, such as a sugar pill. We will use matching placebo for this study.
Drug: Nucleos(t)ide Analogue
Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg-negative hepatitis B.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Parts 1 and 2: Incidence of adverse events (AEs), serious AEs (SAEs), immune related AEs (irAEs) and discontinuations due to AEs and irAEs.
Time Frame: [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs
Time Frame: [Time Frame: Up to 196 days]
[Time Frame: Up to 196 days]
Parts 1 and 2: Incidence of clinically significant laboratory abnormalities Parts 1 and 2: Incidence of clinically significant laboratory abnormalities
Time Frame: [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Parts 1 and 2: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)
Time Frame: [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
[Time Frame: Up to 57 (Part 1) or 84 (Part 2) days]
Part 3: Incidence of clinically significant laboratory abnormalities
Time Frame: [Time Frame: Up to 196 days]
[Time Frame: Up to 196 days]
Part 3: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs)
Time Frame: [Time Frame: Up to 196 days]
[Time Frame: Up to 196 days]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arbutus Biopharma Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

July 14, 2023

First Submitted That Met QC Criteria

July 18, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AB-101-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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