This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study to assess the efficacy and safety of AHB-137 injection in treatment-naïve participants with chronic hepatitis B.
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.
Uncontrolled and stable clinically significant abnormalities other than a history of chronic HBV infection.
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.
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).
Parallel
AHB-137
DrugAHB-137 will be administered subcutaneously.
Placebo
DrugPlacebo will be administered subcutaneously.
HBV DNA < lower limit of quantitation (LLOQ), 10 IU/mL, HBsAg < limit of detection (LOD), 0.05 IU/mL with or without hepatitis B virus surface antibody (HBsAb) 24 weeks after discontinuation of all chronic hepatitis B treatment.
Highly sensitive HBsAg < 0.005 IU/mL and HBV DNA < LLOQ (10 IU/mL) at the end of treatment.
HBV DNA < LLOQ, 10 IU/mL, and HBsAg < 10 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
HBV DNA < LLOQ 24 weeks after discontinuation of all chronic hepatitis B treatment.
HBV DNA < LLOQ and HBsAg < 100 IU/mL 24 weeks after discontinuation of all chronic hepatitis B treatment.
HBsAg seroconversion rate 24 weeks after discontinuation of all chronic hepatitis B treatment.
HBsAg seroconversion : serum HBsAg\<LOD, and at the same time or subsequently, HBsAb\>10 IU/L.
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