Safety, Tolerability, PK & PD of AB-101 Following Oral Administration in Healthy and CHB Subjects.

Launched by ARBUTUS BIOPHARMA CORPORATION · Jul 18, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called AB-101 to see how safe it is and how the body processes it in both healthy adults and people with chronic hepatitis B (CHB). The trial has three parts: the first two parts involve healthy volunteers, while the third part focuses on individuals with CHB who do not have severe liver damage. Researchers are looking for participants who are willing to help advance our understanding of this potential treatment.

To be eligible, healthy volunteers must be men aged 18-50 who can provide consent and follow certain contraception guidelines. For the CHB group, both men and women aged 18-60 with a confirmed chronic hepatitis B infection for at least six months can participate, provided they also meet specific health criteria. Participants can expect to undergo various assessments and will be closely monitored throughout the study to ensure their safety. It's important to note that those with certain health issues, including severe liver damage or infections, will not be eligible to join the trial. This study is an exciting opportunity to help find new treatments for chronic hepatitis B.

Gender

ALL

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.