This study is a four-part and first-in-human study of AHB-137. Parts A and B are randomized, double-blinded, placebo-controlled studies to evaluate the safety, tolerability, pharmacokinetics of AHB-137 following subcutaneous injection in healthy volunteers. Part A is a single-ascending dose (SAD) study and part B is a multiple dose (MD) study. Healthy volunteers will be enrolled and randomized to 6:2 ratio to receive AHB-137 or placebo. Part C and part D are multiple dose studies to assess the safety, tolerability, pharmacokinetics, and antiviral efficacy of AHB-137 in at least 16 CHB patients in multiple centers across multiple regions.~To ensure the objective assessment of the safety and tolerability of AHB-137 in healthy volunteers, study participant, care provider, investigator and clinical outcomes assessor will be blinded to the treatment assignment (AHB-137 vs placebo). Study advancement to subsequent parts/cohorts will require satisfactory interim reviews of available cumulative safety data by the Safety Review Committees (SRC), using the safety criteria and review procedures described in the protocol.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of AHB-137 subcutaneous injection in healthy volunteers and in chronic hepatitis B (CHB) patients after single and multiple doses. In addition, the study will evaluate the antiviral efficacy of AHB-137 in CHB patients following a multiple dosing regimen.