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A Study(Phase I)of GS3-007a Dry Suspension in Healthy Chinese Adults
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
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
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.
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