Phase IIa Randomized, Double-blind, Placebo-controlled Study of GST-HG131 Tablets for Treating Chronic Hepatitis B in Adults Aged 35 to 65

What This Trial Is About

Researchers are conducting a randomized, double-blind, placebo-controlled Phase IIa clinical trial to assess the safety and efficacy of GST-HG131 tablets in adults aged 35 to 65 years with chronic hepatitis B. Participants must be on stable nucleostide analog therapy and meet specific health criteria to join this study. Participants will be randomly assigned in a 41 ratio to receive one of two doses of GST-HG131 or a matching placebo. The treatment periods include 28 days for each dose cohort and a 12-week period for a combined dose group, all while continuing their existing nucleostide analog therapy. The trial evaluates changes in hepatitis B surface antigen levels over these periods. Throughout the study, participants will undergo regular monitoring including blood tests to measure hepatitis B virus levels and safety assessments for adverse events. Researchers will track changes from baseline in HBsAg levels up to 56 days or 16 weeks, depending on cohort, alongside monitoring for any side effects or serious adverse events. The study aims to gather detailed data on the drugs impact and safety profile during the treatment and follow-up periods.

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