Evaluating the safety and effects of AB-101 in healthy individuals and those with chronic hepatitis B.
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.
This study is testing a new treatment called AB-101 to see how safe it is and how it works in both healthy people and those with chronic hepatitis B.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 164 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Arbutus Biopharma Corporation Industry-sponsored |
| Locations | 5 sites (Hong Kong and 4 other locations) |
| Trial ID | NCT05960240 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial investigates the safety, tolerability, pharmacokinetics, and pharmacodynamics of AB-101 through a three-part protocol. The first two parts involve healthy adult volunteers to assess single and multiple ascending doses, while the third part focuses on a dose-ranging assessment in non-cirrhotic chronic hepatitis B patients. The study aims to gather essential data on how AB-101 behaves in the body and its potential effects on chronic hepatitis B.
Who should consider this trial
Good fit: Ideal candidates include males and females aged 18-60 with chronic hepatitis B infection for at least 6 months.
Not a fit: Patients with significant health issues or those with HIV or Hepatitis C may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for patients with chronic hepatitis B.
How similar studies have performed: Other studies have shown promise in similar approaches, but this specific treatment is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Part 1 and 2 (Healthy Volunteers) * Male between ages 18-50 years * Willing and able to provide informed consent Willing to follow protocol-specified contraception requirement Inclusion Criteria: Part 3 (CHB Subjects) * 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 Exclusion Criteria: Part 1 and 2 (Healthy Volunteers) Key Exclusion Criteria: * Clinically significant lab abnormalities * 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. Exclusion Criteria: Part 3 (CHB Subjects) * Have extensive fibrosis or cirrhosis of the liver * 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 * Females who breastfeeding, pregnant or who wish to become pregnant during 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.
Where this trial is running
Hong Kong and 4 other locations
- Prince of Wales Hospital - Hong Kong — Hong Kong, Hong Kong (Recruiting)
- Queen Mary Hospital - PPDS — Hong Kong, Hong Kong (Recruiting)
- Clinial Republican Hospital "Timofei Mosneaga" — Chișinău, Moldova, Republic of (Recruiting)
- New Zealand Clinical Research Auckland — Grafton, Auckland, New Zealand (Recruiting)
- Municipal Non-Profit Enterprise Kyiv City Clinical Hospital No12 Executive Body of Kyiv City Council — Kyiv, Ukraine (Recruiting)
Study contacts
- Study coordinator: Arbutus Biopharma
- Email: clinicaltrials@arbutusbio.com
- Phone: 267-469-0914
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.