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Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HS-10518 in healthy adult premenopausal females in China.


Clinical Trial Description

This is a double-blind, placebo-controlled, multiple-dose, single-center phase 1 study in Chinese healthy premenopausal females aged 18-45 years with a regular menstrual cycle (26-32 days). The main purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HS-10518, a gonadotropin-releasing hormone antagonist. About 48 eligible female subjects will be enrolled. The study contains four cohorts. In each cohort, participants will be randomly assigned to the HS-10518 arm or the placebo arm in a 3:1 ratio. HS-10518/matching placebo will be administered from Day 1 to Day 7. The study duration of each participant is up to ~10 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06118827
Study type Interventional
Source Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact
Status Not yet recruiting
Phase Phase 1
Start date November 1, 2023
Completion date August 30, 2024

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