Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG171 Tablets

Phase 1 Completed 78 enrolled Fujian Akeylink Biotechnology Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

To Evaluate the Safety, Tolerability and Pharmacokinetics on GST-HG171 Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase Ia Clinical Trials in Healthy Subjects

Timeline

Start: 2022-10-01
Primary completion: 2022-12-02
Completion: 2022-12-08

Publications

Zhang H, Zhou J, Chen H, Mao J, Tang Y, Yan W, Zhang T, Li C, Chen S, Li G, Zhang G, Ding Y, Liu L. Phase I study, and dosing regimen selection for a pivotal COVID-19 trial of GST-HG171. Antimicrob Agents Chemother. 2024 Jan 10;68(1):e0111523. doi: 10.1128/aac.01115-23. Epub 2023 Dec 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	GST-HG171	Small molecule	150 mg	Oral
Subject	GST-HG171	Small molecule	300 mg	Oral
Subject	GST-HG171	Small molecule	600 mg	Oral
Subject	GST-HG171	Small molecule	900 mg	Oral

Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG171 Tablets

Summary

Timeline

Publications

Drugs

Indications