Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With Chronic Hepatitis B (CHB)

A Randomized, Multi-center Phase II Study to Evaluate the Efficacy and Safety of AHB-137 in Treatment-naive Participants With CHB

The study is to evaluate the efficacy and safety of AHB-137 in CHB participants. The total duration of the study, including screening phase, treatment phase and follow-up phase.

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;
• Male or female participants aged 18-65 years old (including the boundary value) at the time of signing the ICF;
• Male participants weighed higher than 50 kg and female participants weighted higher than 50 kg, Body Mass Index (BMI) between 18 to 32 kg/m^2(inclusive);
• Participants with positive HBsAg or HBV DNA greater than or equal to (≥) 6 months prior to screening and has not received antiviral treatment with interferon or NAs ;
• At screening, ALT<3×upper limit of normal (ULN);
• Use effective contraception as required;
• HBV DNA within the specified range at screening;
• HBsAg was within the specified range at screening.

Exclusion Criteria:

• Clinically significant abnormalities except chronic HBV infection;
• Any clinically significant liver diseases;
• Participants with severe infection requiring systemic anti-infection treatment 1 month before enrollment;
• Active hepatitis C, HIV antibody positive, treponema pallidum antibody positive;
• Hepatobiliary neoplasm malignant;
• The laboratory examination results are obviously abnormal;
• History of vasculitis or signs and symptoms of potential vasculitis;
• Anti-neutrophil cytoplasmic antibodies (ANCA) was positive at screening.
• History of extrahepatic disease that may be related to HBV immune status;
• Administration of immunosuppressants within 3 months prior to screening, except for short-term use (≤2 weeks) or topical/inhaled steroids. Administration of immunomodulators (thymosin) and cytotoxic drugs within 6 months prior to the first study intervention or have a history of vaccination within 1 month prior to screening or planned administration during the study;
• History of malignancy within the past 5 years or the discovery of suspected tumors during the screening period;
• Any suspicion of drug component allergy, or allergic constitution (various drug and food allergy, and judged by the investigator to be clinically significant) in participants;
• Participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study;
• Blood donation or blood loss more than 400 mL within 12 weeks before screening; Blood transfusion; Blood donation or blood loss not less than 200 mL within 1 month before screening;
• Those who are participating in another clinical trial, or have not undergone a protocol-specified washout period prior to this study;
• Participants who have received any oligonucleotide or small molecule interfering ribonucleic acid (siRNA) drugs;
• Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.