Trials / Completed
CompletedNCT05960240
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.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 128 (actual)
- Sponsor
- Arbutus Biopharma Corporation · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2023-08-30
- Primary completion
- 2025-12-04
- Completion
- 2026-02-09
- First posted
- 2023-07-25
- Last updated
- 2026-04-13
Locations
10 sites across 7 countries: Hong Kong, Italy, Moldova, New Zealand, Romania, Singapore, Ukraine
Source: ClinicalTrials.gov record NCT05960240. Inclusion in this directory is not an endorsement.