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A Study of HS-10518 in Healthy Female Participants - Trial NCT06118827

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.

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NCT06118827
Phase 1
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06118827
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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

Study Focus

Endometriosis

HS-10518

Interventional

drug

Sponsor & Location

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Timeline & Enrollment

Phase 1

Nov 01, 2023

Aug 30, 2024

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

Endometriosis
Other endometriosis
Endometriosis, unspecified
Endometriosis of uterus
Endometriosis of ovary

Data Source

ClinicalTrials.gov

NCT06118827

Non-Device Trial