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Completed

NCT Number: NCT05960240

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Prince of Wales Hospital, Hong Kong

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AB-101

Drug

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.

Placebo

Drug

A placebo is any treatment that has no active properties, such as a sugar pill. We will use matching placebo for this study.

Nucleos(t)ide analogue

Drug

Nucleos(t)ide analogues (NUCs) are the standard and mostly lifelong treatment for chronic HBeAg-negative hepatitis B.

Primary outcomes

  1. 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]

  2. Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs

    Time frame: [Time Frame: Up to 196 days]

  3. 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]

  4. 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]

  5. Part 3: Incidence of clinically significant laboratory abnormalities

    Time frame: [Time Frame: Up to 196 days]

  6. 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]

Sponsors and collaborators

Lead sponsor

Arbutus Biopharma Corporation

Industry

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jul 25, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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