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NCT06118827Not yet recruiting

A Study of HS-10518 in Healthy Female Participants

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HS-10518 in Healthy Adult Premenopausal Females in China
Jiangsu Hansoh Pharmaceutical Co., Ltd.Phase 1ClinicalTrials.govdrug
Study focus
Disease/Condition
Endometriosis
Drug/Device/Intervention
HS-10518
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Timeline & enrollment
Phase
Phase 1
Start date
Nov 01, 2023
End date
Aug 30, 2024
Enrollment
48 participants
Primary outcome

Incidence of Adverse Events (AE) as assessed by CTCAE v4.0,Assessment of safety and tolerability of HS-10518 in terms of the frequency, severity and causality of AEs, serious adverse events (SAEs) and AEs leading to study discontinuation.,Incidence of clinically significant abnormal findings in 12-lead electrocardiogram (ECG)

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.

ICD-10 classifications
EndometriosisOther endometriosisEndometriosis, unspecifiedEndometriosis of uterusEndometriosis of ovary
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06118827
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06118827 through Pure Global AI's free database. This Phase 1 trial is sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. and is currently Not yet recruiting. The study focuses on Endometriosis. Target enrollment is 48 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.