Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB-101 Following Oral Administration in Healthy and Chronic Hepatitis B Subjects
- Conditions
- Chronic Hepatitis b
- Interventions
- Registration Number
- 2023-508312-39-00
- Lead Sponsor
- Arbutus Biopharma Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 128
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 3 AB-101 - Part 1 Placebo - Part 2 Placebo - Part 3 Nucleos(t)ide Analogue - Part 3 Placebo - Part 2 AB-101 - Part 1 AB-101 -
- Primary Outcome Measures
Name Time Method Parts 1 and 2: Incidence of adverse events (AEs), serious AEs (SAEs), immune related AEs (irAEs) and discontinuations due to AEs and irAEs. [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days] Part 3: Incidence of AEs, SAEs, irAEs and discontinuations due to AEs and irAEs [Time Frame: Up to 196 days] Parts 1 and 2: Incidence of clinically significant laboratory abnormalities Parts 1 and 2: Incidence of clinically significant laboratory abnormalities [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days] Parts 1 and 2: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs) [Time Frame: Up to 57 (Part 1) or 84 (Part 2) days] Part 3: Incidence of clinically significant laboratory abnormalities [Time Frame: Up to 196 days] Part 3: Incidence of clinically significant changes in vital signs (heart rate, blood pressure, temperature, respiratory rate), physical examinations and electrocardiograms (ECGs) [Time Frame: Up to 196 days]
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- 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
Clinial Republican Hospital "Timofei Mosneaga"
🇲🇩Chișinău, Moldova, Republic of
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
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Prince of Wales Hospital🇭🇰Hong Kong, Hong Kong