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

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: Completed
• Conditions: Chronic Hepatitis b
• Intervention / Treatment: Drug: AB-101; Drug: Placebo; Drug: Nucleos(t)ide Analogue

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 1

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong
    • Hong Kong, Hong Kong, Hong Kong
      • Prince of Wales Hospital
    • Hong Kong, Hong Kong, Hong Kong
      • Queen Mary Hospital - PPDS
• Italy
  • Bergamo, Italy
    • ASST Papa Giovanni XXIII -Osepedale
  • Milan, Italy
    • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
• Moldova
  • Chisinau, Moldova
    • Clinial Republican Hospital "Timofei Mosneaga"
• New Zealand
  • Auckland
    • Grafton, Auckland, New Zealand
      • New Zealand Clinical Research Auckland
• Romania
  • Bucharest, Romania
    • Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E. M.
• Singapore
  • Singapore, Singapore
    • National University Hospital
  • Singapore, Singapore
    • Singapore General Hospital
• Ukraine
  • Kyiv, Ukraine
    • Municipal Non-Profit Enterprise Kyiv City Clinical Hospital No12 Executive Body of Kyiv City Council

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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: 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: 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: 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: Up to 57 (Part 1) or 84 (Part 2) days]
Part 3: Incidence of clinically significant laboratory abnormalities	[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: Up to 196 days]

Collaborators and Investigators

• Sponsor: Arbutus Biopharma Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Actual): December 4, 2025
• Study Completion (Actual): February 9, 2026

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): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis; Pathological Conditions, Signs and Symptoms; Hepatitis B; Hepatitis B, Chronic
• 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
• product manufactured in and exported from the U.S.: No