A Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AB-729 Administered by Subcutaneous Injection to Subjects with Chronic Hepatitis B Infection

Abstract

The study drug AB-729 is being developed as a potential new treatment for Chronic Hepatitis B (CHB). The main goal of the study is to determine whether AB-729 is safe and well tolerated when given at different doses. We will also measure the levels of the drug in the blood at different times. The study will be conducted in 3 parts.

Study Part 1 (Healthy Subjects SAD) : Part 1 will enroll 24 healthy subjects using a SAD design consisting of 4 sequential dose groups

Study Part 2 (Subjects with CHB Infection SAD): Once the safety and tolerability data from the first 2 doses of the SAD assessment in healthy subjects have been completed and it is considered safe to proceed by the SRC, Part 2 will commence in subjects with CHB infection.

Study Part 3 (Subjects with CHB Infection MD): Part 3 will be an open-label, Non-Randomized, MD design and will be conducted in 35 subjects with CHB infection. Discontinuation of all HBV treatment is optional. If subjects stop all therapy, they will enter a more intensive follow-up period for 12 months and then have quarterly visits for up to 2 additional years for a total of up to 3 years of follow-up post-NA discontinuation