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

NCT05960240 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Arbutus Biopharma Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-30
Primary Completion
2025-12-04
Completion
2026-02-09

Countries

  • Hong Kong
  • Italy
  • Moldova
  • New Zealand
  • Romania
  • Singapore
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05960240 on ClinicalTrials.gov