Evaluation of The Safety, Efficacy and Pharmacokinetic Characteristics of GST-HG141 Tablets

Phase 2 Completed 90 enrolled Fujian Akeylink Biotechnology Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

A Randomized, Double-blind, Placebo-controlled and Multicenter Phase Ⅱ Clinical Trials To Evaluate the Safety, Efficacy and Pharmacokinetics of GST-HG141 Tablets in Treated Chronic Hepatitis B (CHB) Patients With Low Viremia.

Timeline

Start: 2023-01-03
Primary completion: 2024-07-24
Completion: 2024-08-24

Outcome

Met primary endpoint

paper 84.0% of patients in the low-dose group and 81.5% in the high-dose group achieved HBV DNA <20 IU/mL PMID 40808966 ↗

paper p < 0.05 for both treatment groups vs. placebo PMID 40808966 ↗

Publications

Wang C, Kong F, Gao H, Cai D, Zhang G, Ning Q, Zhong B, Liu Z, Su Z, Wu G, Hou J, Mao J, Zhang T, Wu W, Yan W, Yan X, Li G, Gao Y, Zhang G, Niu J. Safety and efficacy of GST-HG141, a novel HBV capsid assembly modulator, for the treatment of chronic hepatitis B patients with low-level viremia: a randomized, double-blind, placebo-controlled, multicenter phase II study. EClinicalMedicine. 2025 Aug 2;87:103400. doi: 10.1016/j.eclinm.2025.103400. eCollection 2025 Sep.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Neracorvir	Other / unclassified	50 mg	Oral
Subject	Neracorvir	Other / unclassified	100 mg	Oral