NCT05668897

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Fujian Akeylink Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	GST-HG171	This study includes single-dose ascending and multiple-dose ascending studies. SAD study contains at least 4 dose groups of 150 mg, 300 mg, 600 mg and 900 mg. MAD study contains 1-3 dose groups which were evaluated in SAD study to be tolerated.
DRUG	placebo of GST-HG171	This study includes single-dose ascending and multiple-dose ascending studies. SAD study contains at least 4 dose groups of 150 mg, 300 mg, 600 mg and 900 mg. MAD study contains 1-3 dose groups which were evaluated in SAD study to be tolerated.

Timeline

• Start date: 2022-10-01
• Primary completion: 2022-12-02
• Completion: 2022-12-08
• First posted: 2022-12-30
• Last updated: 2023-10-12

Locations

1 site across 1 country: China