A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 Tablets in Patients With Chronic Hepatitis B
Trial Parameters
Brief Summary
A randomized, double-blind, placebo-controlled Phase IIa clinical study to evaluate the safety and efficacy of GST-HG131 tablets in patients with chronic hepatitis B
Eligibility Criteria
Inclusion Criteria: 1. Able to sign the informed consent form，and fully understand the test content, process and possible adverse reactions； 2. Males and females aged 35-65 ,able to complete research in accordance with test plan requirements; 3. Participants who have no childbearing plan in next 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； 4. The weight of male patients shall not be less than 50 kg, and the weight of female patients is not less than 45 kg. Body mass index (BMI = weight (kg)/height 2 (m2)) in the range of 18.0\~35.0 kg/m2； 5. Participants who have received stable NA therapy for more than half a year and have maintained the NA regimen for ≥3 months prior to screening； 6. At least two tests within 28 days of the screening period (more than 1 week apart) with HBV DNA lower than LLOQ； 7. HBeAg negative, 100≤HBsAg quantitative ≤1500 IU/mL, serum ALT\<1×ULN during screen