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RECRUITING
NCT07473570
PHASE1

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

Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

32

Start Date

2026-01-07

Completion Date

2026-08

Last Updated

2026-03-16

Healthy Volunteers

Yes

Conditions

Interventions

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.

Locations (1)

Yuehong Plaza, No. 88 Hongcao Road, Xuhui District, Shanghai

Shanghai, Shanghai Municipality, China