Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.
Chronic Hepatitis b
About this trial
This is an interventional treatment trial for Chronic Hepatitis b
Eligibility 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.
Sites / Locations
- New Zealand Clinical Research Auckland
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Part 1
Part 2
Part 3