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

Korábbi kezelés

• 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;
• Participants with severe infection requiring intravenous anti-infection treatment 1 month before randomization;
• 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.
• Administration of any Interferon within 6 months prior to screening;
• 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;
• 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;
• Any oligonucleotide or siRNA treatments within 12 months prior to first dosing;

Más betegség

• 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.;
• Active hepatitis C, Human immunodeficiency virus (HIV) positive, syphilis positive;
• History of vasculitis or signs and symptoms of potential vasculitis;
• History of extrahepatic disease that may be related to HBV immune status;
• History of malignant tumor within the past 5 years;
• 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;
• Any other circumstances or conditions for which the investigator considers that the participants are inappropriate to participate in the study.

Laborértékek

• The laboratory examination results are obviously abnormal;

Egyéb

• Liver stiffness measurement (LSM) > 9.0 kPa when screening;
• Diagnosed or suspected hepatocellular carcinoma;

• 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;
• At least 18 years old at the time of signing of the informed consent;
• Body Mass Index (BMI) between 18 to 32 kg/m\^2(inclusive) ;
• Participants who are Hepatitis B envelop antigen (HBeAg) negative during screening;
• Participants whose serum HBsAg positive for at least 6 months prior to screening;
• Participants who have stable on NA therapy at least 6 months prior to screening;
• Participants with HBsAg concentration >100 IU/mL and≤3000 IU/mL, HBV DNA<100 IU/mL;
• Participants with alanine aminotransferase (ALT)≤ 2x upper limit of normal (ULN);
• 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.