study to evaluate the efficacy and safety of ahb-137 in treatment-naive participants with chb with low viral load

Conditions: Chronic Hepatitis B

Summary: the study is to evaluate the efficacy and safety of ahb-137 in chb participants. about 60 participants will be recruited and randomly divided into two arms.the arms will be stratified based on hbsag level (hbsag greater than\[\>\] 100 international unit per milliliter \[iu/ml\] to less than or equal to \[≤\]3000 iu/ml or greater than \[\>\] 3000 iu/ml to ≤10000 iu/ml) at screening. the total duration of the study, including screening phase (up to 28 days), treatment phase (16 weeks), and follow-up phase (24 weeks), with a total study duration of approximately 44 weeks for each participant.


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 according to the protocol; 2. male or female participants aged 18-65 years old (including the boundary value) at the time of signing the icf; 3. male participants weighed higher than 50kg and female participants weighted higher than 50 kg, body mass index (bmi) between 18 to 32 kg/m\^2(inclusive); 4. 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 nucleos(t)ide analogue ; 5. at screening, 20 iu/ml\<hbv dna≤2000 iu/ml; 6. at screening, 100 iu/ml\<hbsag≤10000 iu/ml; 7. at screening, alt\<3×upper limit of normal (uln); 8. for women with childbearing potential should be non-pregnant or non-lactating during screening, and participants 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. clinically significant abnormalities except chronic hbv infection; 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, imaging-diagnosed moderate to severe fatty liver, drug-induced liver injury, history of hereditary liver disease, etc.; 3. participants with severe infection requiring systemic anti-infection treatment 1 month before randomization; 4. co-infection with current or past history of hepatitis c virus (hcv), human immunodeficiency virus (hiv), hepatitis d virus (hdv). 5. participants who have had or currently have cirrhosis or currently have progressive liver fibrosis; 6. participants who have had or currently have hepatobiliary system tumor; or blood alpha-fetoprotein (afp) ≥ 20 ng/ml during screening, or the liver b-ultrasound, ct, mri and other imaging examinations suggested the possibility of hepatobiliary system tumors; 7. the laboratory examination results are obviously abnormal; 8. history of vasculitis or signs and symptoms of potential vasculitis; 9. anti-neutrophil cytoplasmic antibodies (anca) was positive at screening. 10. history of extrahepatic disease that may be related to hbv immune status; 11. 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; 12. history of malignancy within the past 5 years or the discovery of suspected tumors during the screening period; 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, whichever is longer; 17. participants who have received any oligonucleotide or small molecule interfering ribonucleic acid (sirna) drugs; 18. any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.

Keywords: hepatitis b, chronic