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ACTIVE NOT RECRUITING
NCT05960240
PHASE1

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

Sponsor: Arbutus Biopharma Corporation

View on ClinicalTrials.gov

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.

Official 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.

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

128

Start Date

2023-08-30

Completion Date

2026-04

Last Updated

2025-07-18

Healthy Volunteers

Yes

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.

Locations (10)

Prince of Wales Hospital

Hong Kong, Hong Kong

Queen Mary Hospital - PPDS

Hong Kong, Hong Kong

ASST Papa Giovanni XXIII -Osepedale

Bergamo, Italy

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Italy

Clinial Republican Hospital "Timofei Mosneaga"

Chisinau, Moldova

New Zealand Clinical Research Auckland

Grafton, Auckland, New Zealand

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

Bucharest, Romania

National University Hospital

Singapore, Singapore

Singapore General Hospital

Singapore, Singapore

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

Kyiv, Ukraine