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

NCT05960240 | Completed Phase 1 DMC

• 1 other identifier: AB-101-001
• Study Type: interventional
• Target: 128
• Locations: 7 countries
• Sites: 10

Brief Summary

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.

Conditions

Chronic Hepatitis b

Outcome Measures

Primary Outcomes (6)

• 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]

Study Arms (3)

Part 1

EXPERIMENTAL

Drug: AB-101; Drug: Placebo

Part 2

EXPERIMENTAL

Drug: AB-101; Drug: Placebo

Part 3

EXPERIMENTAL

Drug: AB-101; Drug: Placebo; Drug: Nucleos(t)ide Analogue

Interventions

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.

Part 1; Part 2; Part 3

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.

Part 1; Part 2; Part 3

Nucleos(t)ide Analogue DRUG

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

Part 3

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male between ages 18-50 years
• Willing and able to provide informed consent
• Willing to follow protocol-specified contraception requirement
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Arbutus Biopharma Corporation: lead

Study Sites (10)

Prince of Wales Hospital

Hong Kong, Hong Kong, Hong Kong

Location

Queen Mary Hospital - PPDS

Hong Kong, Hong Kong, Hong Kong

Location

ASST Papa Giovanni XXIII -Osepedale

Bergamo, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

Location

Clinial Republican Hospital "Timofei Mosneaga"

Chisinau, Moldova

Location

New Zealand Clinical Research Auckland

Grafton, Auckland, New Zealand

Location

Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E. M.

Bucharest, Romania

Location

National University Hospital

Singapore, Singapore

Location

Singapore General Hospital

Singapore, Singapore

Location

Municipal Non-Profit Enterprise Kyiv City Clinical Hospital No12 Executive Body of Kyiv City Council

Kyiv, Ukraine

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2023
• First Posted: July 25, 2023
• Study Start: August 30, 2023
• Primary Completion: December 4, 2025
• Study Completion: February 9, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

NZ (1); SG (2); IT (2); RO (1); UA (1); HK (2); MO (1)