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Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.
Sponsor: Arbutus Biopharma Corporation
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
Conditions
Interventions
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.
Placebo
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
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