Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE)

A Randomized, Double-blind, Multicenter Phase III Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With HBeAg-negative Chronic Hepatitis B Treated With Nucleos(t)Ide Analogues

This study is a randomized, double-blind, multicenter phase 3 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with HBeAg-negative CHB treated with NAs.

Inclusion Criteria:

• Participants voluntarily participate in the study, and sign the Informed Consent Form (ICF) prior to screening, able to complete the study according to the protocol;
• At least 18 years of age at the time of signing the ICF;
• Body mass index met the requirements;
• HBeAg negative at screening;
• HBsAg or HBV DNA positive for at least 6 months;
• Meet relevant requirements for NAs treatment;
• 100 IU/mL < HBsAg ≤ 3000 IU/mL, HBV DNA < 100 IU/mL and liver function indicators meet the requirements;
• Effective contraception as required.

Exclusion Criteria:

• Clinically significant abnormalities other than a history of chronic HBV infection;
• Concomitant clinically significant other liver diseases;
• Previous/current manifestations of hepatic decompensation;
• Significant hepatic fibrosis or cirrhosis;
• Presence of protocol-specified laboratory abnormalities;
• History of malignancy or ongoing assessment of possible malignancy;
• Those allergic to AHB-137 or its components;
• Participants with recent major trauma or major surgery, or planning surgery;
• Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
• Prior/current use of prohibited medications;
• Inappropriate for participation in this trial as judged by the investigator.