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NOT YET RECRUITING
NCT07302035
PHASE1

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

GenSci142

Vaginal insert

DRUG

Placebo GenSci142

Vaginal insert

Locations (1)

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China