NCT07264192

A Study of HS-10518 in Healthy Adult Premenopausal Females in China

A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10518 in Healthy Adult Premenopausal Females in China

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: West China Second University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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

Detailed description

In this randomized, double-blind, placebo-controlled Phase I clinical trial, 60 participants were randomized in a 1:1:1:1:1:1 ratio to receive HS-10518 (10 mg Q12h, 20 mg QD, 20 mg Q12h, 40 mg QD, or 80 mg QD) or placebo for 14 consecutive days. Assessments included safety, tolerability, PK parameters, and PD parameters.

Conditions

• Infertility, Female

Interventions

Type	Name	Description
DRUG	HS-10518	During the Dosing Period, four capsules of HS-10518 are administered twice daily at the same time points each day (morning and evening). The capsules should be swallowed whole with approximately 240 mL of water, and fluid intake is restricted within 1 hour before and after drug administration. Consecutive dosing should be maintained for 14 days.
DRUG	Placebo	During the Dosing Period, four capsules of HS-10518 Placebo are administered twice daily at the same time points each day (morning and evening). The capsules should be swallowed whole with approximately 240 mL of water, and fluid intake is restricted within 1 hour before and after drug administration. Consecutive dosing should be maintained for 14 days.

Timeline

• Start date: 2025-03-11
• Primary completion: 2025-06-23
• Completion: 2025-09-09
• First posted: 2025-12-04
• Last updated: 2026-03-25

Locations

1 site across 1 country: China