A Phase 2 Multi-center, Randomized, Open-label Study to Assess the Efficacy and Safety of AHB-137 in Nucleos(t)Ide Analogue-treated Participants With HBeAg Negative Chronic Hepatitis B in the Asia Pacific Region
This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.
‣ Participants are eligible to be included in the study only if all of the following criteria apply:
• Adults ≥18 years of age (or per local age of majority) and ≤65 years of age at Screening who are able to provide informed consent, comply with study procedures, and agree to discontinue nucleos(t)ide analog (NA) therapy if protocol-defined discontinuation criteria are met.
• Body mass index (BMI) ≤35 kg/m².
• Documented chronic hepatitis B virus (HBV) infection for ≥6 months prior to randomization, defined by hepatitis B surface antigen (HBsAg) positivity or detectable HBV DNA.
• Hepatitis B e antigen (HBeAg) negative at Screening.
• Receiving stable, approved nucleos(t)ide analog (NA) monotherapy for ≥6 months prior to randomization.
• HBV DNA below the lower limit of quantification (LLOQ) at Screening.
• Hepatitis B surface antigen (HBsAg) level \>100 IU/mL and ≤3,000 IU/mL at Screening.
• Alanine aminotransferase (ALT) ≤2 × upper limit of normal (ULN) at Screening.
• Screening electrocardiogram (ECG) without clinically significant abnormalities and with a Fridericia-corrected QT interval (QTcF) ≤450 msec for males or ≤470 msec for females.
⁃ Females of childbearing potential must not be breastfeeding and must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to first dose.
⁃ Male and female participants of childbearing potential must agree to use protocol-specified effective contraception during the dosing period and for ≥6 months after the last dose of AHB-137.