NCT05345964

Phase I Study of GST-HG151 Tablets in Healthy Volunteers

A Safety, Tolerability, Pharmacokinetics, and Food Impact Phase I Study of GST-HG151 Tablets in Single-dose and Multiple-dose in Healthy Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Fujian Cosunter Pharmaceutical Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Impact of GST-HG151 Tablets in Single-dose and Multiple-dose in Healthy Volunteers

Detailed description

This trial includes single-dose studies,multiple-dose studies and food Impact studies, The single-dose study included eight doses groups of 5 mg, 15 mg, 30 mg, 60 mg, 90mg, 120 mg, 150 mg and 180 mg. Based on the results of a single dose, select 2 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-HG151 pharmacokinetics.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GST-HG151	Subjects will take GST-HG151 orally(once daily) on Day 1
DRUG	Placebo	Subjects will take Placebo orally(once daily) on Day 1
DRUG	GST-HG151	Subjects will take GST-HG151 orally (once daily) from Day 1 to Day 7
DRUG	Placebo	Subjects will take Placebo orally (once daily) from day 1 to day 7
DRUG	GST-HG151	Group A was administered under the fasting condition of Day1 in the first cycle, and under the postprandial conditions of Day8 \~ Day15 in the second cycle. The two cycles are cross-administered, and the cleaning period is 7 to 14 days.
DRUG	GST-HG151	Group B was administered under the postprandial conditions of Day1 in the first cycle, and under the sky-abdominal conditions of Day8 \~ Day15 in the second cycle. The two cycles are cross-administered, and the cleaning period is 7 to 14 days.

Timeline

• Start date: 2022-03-07
• Primary completion: 2023-03-31
• Completion: 2023-05-31
• First posted: 2022-04-26
• Last updated: 2022-04-26

Locations

1 site across 1 country: China