study to evaluate the efficacy and safety of ahb-137 injection in subjects with chronic hepatitis b (chb).

Conditions: Hepatitis B, Chronic

Summary: ab-10-8003 is a randomized, multi-center phase ii study to evaluate the efficacy and safety of ahb-137 in subjects with hbeag-negative chb under stable na treatment.

the study is to evaluate the efficacy and safety of ahb-137 in hbeag-negative chb subjects. about 60 subjects will be recruited and randomly divided into two cohorts. the total duration of the study, including screening phase (up to 28 days), ahb-137 on treatment phase (up to 24 weeks); ahb-137 off treatment phase (24 weeks); and follow-up phase (24 weeks). cohort a will be treated with ahb-137 for 24 weeks during the ahb-137 on treatment phase, while cohort b will be administered with placebo for the first 8 weeks followed by ahb-137 dosing for 16 weeks during the ahb-137 on treatment phase.

Eligibility criteria:
inclusion criteria: 1. participants voluntarily participate in the study, and sign the informed consent form (icf) prior to screening, able to complete the study and discontinue their na therapy according to the protocol; 2. at least 18 years old at the time of signing of the informed consent; 3. body mass index (bmi) between 18 to 32 kg/m\^2(inclusive) ; 4. participants who are hepatitis b envelop antigen (hbeag) negative during screening; 5. participants whose serum hbsag positive for at least 6 months prior to screening; 6. participants who have stable on na therapy at least 6 months prior to screening; 7. participants with hbsag concentration \>100 iu/ml and≤3000 iu/ml, hbv dna\<100 iu/ml; 8. participants with alanine aminotransferase (alt)≤ 2x upper limit of normal (uln); 9. for women of childbearing potential, she should be non-pregnant or non-lactating during screening, and participants (and partners) are willing to take effective contraceptive measures from the screening until the last visit or at least 6 months after the last dosing. exclusion criteria: 1. clinical significant abnormalities except chronic hbv infection, such as acute coronary syndrome within 6 months before screening, evidence of major surgery, major or unstable heart disease, bleeding tendency or significant coagulation disorder within 3 months before screening; 2. any clinically significant liver diseases, including but not limited to hepatitis caused by other pathogenic infections, hemochromatosis, wilson disease, primary biliary cirrhosis, autoimmune liver diseases, alcoholic liver disease, severe non-alcoholic fatty liver disease, drug-induced liver injury, etc.; 3. participants with severe infection requiring intravenous anti-infection treatment 1 month before randomization; 4. co-infection with: hepatitis c virus, human immunodeficiency virus (hiv) and hepatitis d virus; 5. liver stiffness measurement (lsm)≥9.0 kpa when screening; 6. diagnosed or suspected hepatocellular carcinoma; 7. the laboratory examination results are obviously abnormal; 8. history of vasculitis or signs and symptoms of potential vasculitis; 9. history of extrahepatic disease that may be related to hbv immune status; 10. 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. 11. administration of any interferon within 6 months prior to screening; 12. history of malignant tumor within the past 5 years; 13. 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; 14. participants who have significant trauma or major surgery within 3 months before screening, or plan to perform surgery during the study; 15. 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; 16. concurrently participating in another clinical study, or received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the study treatment or 90 days; 17. any oligonucleotide or sirna treatments within 12 months prior to first dosing; 18. any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.