NCT05960240CompletedPhase 1
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.
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 128 (actual)
- First submitted
- 14 Jul 2023
- Start date
- 30 Aug 2023
- Primary completion date
- 4 Dec 2025
- Lead sponsor
- Arbutus Biopharma Corporation
- Diseases
- Hepatitis B
- NCT number
- NCT05960240
- EU CT number
- 2023-508312-39-00
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 128
- From 30 Aug 2023 to the primary completion date, 4 Dec 2025
- 12 sites in 8 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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 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
- 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.
Other
- Clinically significant lab abnormalities
- Have extensive fibrosis or cirrhosis of the liver
- Females who breastfeeding, pregnant or who wish to become pregnant during the study
Who the study is looking for
- 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
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Military Medical Academy Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Completed |
| Umbal - Prof. D-R Stoyan Kirkovich AD Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Completed |
| Queen Mary Hospital - PPDS Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Prince of Wales Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Completed |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Completed |
| Clinial Republican Hospital "Timofei Mosneaga" Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| New Zealand Clinical Research Auckland Coordinator of this site? Confirm its status | Grafton | New Zealand | Unknown status |
| Institutul National de Boli Infectioase "Prof.Dr. Matei Bals" Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Singapore General Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| National University Hospital Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| Municipal Non-Profit Enterprise Kyiv City Clinical Hospital No12 Executive Body of Kyiv City Council Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.