NCT07473570

A Study（Phase I）of GS3-007a Dry Suspension in Healthy Chinese Adults

A Phase I Clinical Study of GS3-007a Dry Suspensions in Healthy Chinese Adults: Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Dose, Dose-Escalation, and Food Effect Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study consists of two parts: the first part is a single-dose escalating（SAD） and food effect （FE）study, and the second part is a multiple-dose (14-day) escalating(MAD) study. Both phases are designed as randomized, double-blind, dose-escalation, placebo-controlled clinical studies.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	GS3-007a for Suspension	GS3-007a dry suspension for oral use. Each sachet contains 50 mg of GS3-007a. The dry suspension is reconstituted with water before administration. Dosing is based on body weight, as specified in the arm descriptions. The product should be stored protected from light, in a sealed container, at or below 25°C.
DRUG	Placebo GS3-007a for Suspension	Placebo dry suspension matching GS3-007a in appearance, odor, and packaging. It contains all excipients except the active ingredient, with added bitter agent. It is reconstituted with water before administration. Dosing is based on body weight, as specified in the arm descriptions. Storage conditions are the same as for the active drug.

Timeline

• Start date: 2026-01-07
• Primary completion: 2026-06-01
• Completion: 2026-08-01
• First posted: 2026-03-16
• Last updated: 2026-03-16

Locations

1 site across 1 country: China