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A First-in-Human Safety and Pharmacokinetic Trial of GenSci142 Administered as Single Ascending Doses in Healthy Chinese Women
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Summary
This is a Phase Ia single-center, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, Pharmacokinetic of GenSci142 in Chinese healthy women.
Official title: A Phase Ia Single-Center, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Trial of GenSci142 Administered in Single Ascending Doses in Healthy Chinese Women
Key Details
Gender
FEMALE
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-12
Completion Date
2026-12
Last Updated
2025-12-24
Healthy Volunteers
Yes
Conditions
Interventions
GenSci142
Vaginal insert
Placebo GenSci142
Vaginal insert
Locations (1)
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China