A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131/GST-HG141 tablets in patients with chronic hepatitis B
Able to sign the informed consent form and fully understand the test content, process and possible adverse reactions.
Males and females aged 35-65 years(inclusive),able to complete research in accordance with test plan requirements.
Participants who have no childbearing plan in a year,and must agree to voluntarily use the contraceptive methods specified in the protocol from screening to 6 months after the last dose of the study.
Male body weight ≥ 50 kg, female body weight ≥ 45 kg, with a body mass index (BMI) of 18-30 kg/m2 (inclusive).
Participants with a history of allergy to any component of the investigational product, or allergic diathesis (allergies to multiple drugs and foods).
Participants unable to tolerate venous blood collection, or with a history of needle syncope or blood phobia.
Participants who sustained major trauma or underwent major surgery within 3 months prior to screening, or those planning to undergo surgery during the study period.
Participants with a history of alcohol abuse (defined as alcohol intake >14 standard units per week; one standard unit equals 350 mL beer, 120 mL wine, or 30 mL spirits with 40% alcohol by volume) or drug abuse/dependence at screening.
Parallel
GST-HG141
DrugGST-HG141 is a novel, potent and selective HBV CAM, which has a distinct molecular mechanism of its antiviral action compared to other CAMs reported in the literature, and has demonstrated strong antiviral properties in pre-clinical studies in vitro and in vivo.
GST-HG131
DrugGST-HG131 is a novel dihydroquinolizinone (DHQ) compound, has been shown to reduce circulating levels of HBsAg in animals.
GST-HG141 Placebo
DrugGST-HG141 Placebo
HBsAg decline from baseline at D168
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