A Study to Evaluate AHB-137 Injection in Treatment-naïve Participants With Chronic Hepatitis B

Ki vehet részt

• Volunteer to participate and sign the informed consent form, and are willing to complete the study in accordance with the requirements of the protocol
• Aged 18-65 years (including boundary values)
• Body mass index between the range of 18-32 kg/m2 (inclusive boundary values)
• HBsAg or HBV DNA positive for ≥ 6 months at screening and no antiviral treatment with interferon or nucleoside analogue
• HBsAg and HBV DNA values met protocol requirements at screening
• ALT < 3xULN at screening
• Use highly effective contraception as required

Ki nem vehet részt

• Participants with other clinically significant liver diseases, previous/current manifestations of hepatic decompensation, and a history of extrahepatic diseases that may be related to HBV immune status
• Any serious infection other than chronic hepatitis B infection requiring intravenous anti-infective therapy within 1 month prior to randomization
• Major trauma or major surgery within 3 months prior to screening, or planned surgery during the trial
• Current use or use of any immunosuppressive medication (e.g. prednisone) within 3 months prior to screening, except for short courses (≤ 2 weeks) or use of topical/inhaled steroids;Those who have used immunomodulators within 3 months prior to screening;Those who have used cytotoxic drugs within 6 months prior to screening;History of vaccination within 1 month prior to screening or a live vaccination plan during the trial
• Participants that have received any antisense oligonucleic acid, siRNA, capsid assembly modulator (CAM) antiviral drug used to treat chronic hepatitis B
• Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection
• Hepatitis C virus (HCV) infection or < 12 months from cure at screening (HCV RNA positive within 12 months), human immunodeficiency virus (HIV) positive at screening, and syphilis positive (treponema pallidum antibody positive)
• Participants with confirmed or suspected liver cancer who have a history of malignancy within the past 5 years or are undergoing assessment for a possible malignancy
• Allergic to AHB-137 ingredients, or history of drug allergy or other allergies
• Any other circumstances or conditions in which, in the opinion of the investigator, the participant is inappropriate for participation in this trial
• Laboratory test results do not meet the criteria
• Prior/current autoimmune disease, history of vasculitis, or presence of signs, symptoms, or laboratory tests of underlying vasculitis
• Fridericia ' s formula corrected QT interval (QTcF) ≥ 450 msec for male participants and ≥ 470 msec for female participants at screening
• Significant fibrosis or cirrhosis, or liver stiffness value (LSM) > 9.0 kPa at screening
• Participants are participating in another clinical trial or failing to wash out as required
• Participants that require regular long-term anticoagulants
• Abnormal thyroid function