NCT05991362

A Phase I Study of GFH312 in Healthy Chinese Subjects

A Randomized, Double-blind, Placebo-controlled, Single-dose and Multiple-dose Study Evaluating the Pharmacokinetics and Safety of GFH312 in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Zhejiang Genfleet Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of this study was to evaluate the pharmacokinetic profile and observe the safety of GFH312 after single and multiple administrations in healthy Chinese subjects.

Detailed description

This study was planned to enroll about 26 healthy subjects, subjects were planned to receive single administration of 100 mg GFH312, single administration of 200 mg GFH312, or multiple administrations of 120 mg GFH312, as well as their matching placebo. Subjects were randomized in 3:1 ratio in the single dose cohorts and in 4:1 ratio in the multiple dose cohort.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	GFH312 100 mg	Participants receive single dose of GFH312 100 mg orally
DRUG	GFH312 200 mg	Participants receive single dose of GFH312 200 mg orally
DRUG	GFH312 120mg	Participants receive daily dose of GFH312 120mg orally for fourteen consecutive days
OTHER	Placebo	Participants receive placebo matching with GFH312

Timeline

• Start date: 2022-11-29
• Primary completion: 2023-02-13
• Completion: 2023-05-30
• First posted: 2023-08-14
• Last updated: 2023-08-23

Locations

1 site across 1 country: China