NCT04499443

Safety, Tolerability and Pharmacokinetic Characteristics Evaluation of GST-HG131 Tablets

To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG131 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Fujian Cosunter Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG131 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects

Detailed description

This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100mg, 150 mg, 200 mg, 250 mg and 300 mg. Based on the results of a single dose, select 1 to 3 doses to conduct multiple dose studies. To evaluate the tolerance of GST-HG131 tablets in healthy subjects in single and multiple administrations, pharmacokinetic characteristics, drug metabolism and transformation, and the effect of food on GST-HG131 pharmacokinetics.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	GST-HG131 tablets	This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100 mg, 150 mg, 200 mg, 250mg and 300 mg. Based on the results of a single dose, select 1 to 3 doses to conduct multiple dose studies.
DRUG	Placebo	This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100 mg, 150 mg, 200 mg, 250mg and 300 mg. Based on the results of a single dose, select 1 to 3 doses to conduct multiple dose studies.

Timeline

• Start date: 2020-08-18
• Primary completion: 2021-03-31
• Completion: 2021-05-31
• First posted: 2020-08-05
• Last updated: 2020-09-24

Locations

1 site across 1 country: China