A Study of HS-10518 in Healthy Female Participants

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06118827
• Other study ID #: HS-10518-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: November 1, 2023
• Est. completion date: August 30, 2024

Study information

• Verified date: October 2023
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: August 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• • Subject is a healthy premenopausal female aged 18-45 (inclusive) at Screening;
• Subject has a body weight =45kg with a body mass index (BMI) of 18-28 kg/m^2 (inclusive);
• Subject has a normal menstrual cycle for no less than 2 years (Cycle: 26-32 days, menstrual period: 2-7 days), and have a positive ovulation test in the cycle prior to drug administration;
• Subject is willing to use highly effective, non-hormone contraceptive methods from signing the consent form until 3 months after the last dose;
• Subject agrees to draw blood in pre-specified time points throughout the study and to attend the follow-up visit;
• Subject is able to understand the purpose, process and potential adverse events of the study, and is willing to sign a written informed consent form.

Exclusion Criteria:

• • Subject took caffeine-rich or xanthine-rich food or drink (e.g. coffee, tea, chocolate, cola, etc.), tobacco or alcoholic products within 48 hours prior to drug administration;
• Subject took any grapefruit, grapefruit juice or other products within 7 days prior to first dose of study drug;
• Subject has a positive breath alcohol test or a history of alcohol abuse;
• Subject is a heavy smoker, or smokes =5 cigarettes per day, or is not able to cease smoking during the study (including e-cigarette);
• Subject has a history of drug abuse or a positive urine drug test;
• Subject is pregnant, breastfeeding or has a positive pregnancy test at Screening

Related Conditions & MeSH terms

• Endometriosis

Intervention

Drug:
• HS-10518
QD, orally for 7 days
• Placebo
QD, orally for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events (AE) as assessed by CTCAE v4.0	Assessment of safety and tolerability of multiple-dose HS-10518 in healthy female subjects in terms of the frequency, severity and causality of AEs, serious adverse events (SAEs) and AEs leading to study discontinuation. CTCAE v4.0 will be used for classification and severity determination.	From screening to day 16
Primary	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 any markedly abnormal standard vital sign measurements is collected throughout study.	From screening to day 16
Primary	Incidence of clinically significant abnormal findings in 12-lead electrocardiogram (ECG)	Incidence of any clinically significant abnormal findings in 12-lead ECG is collected throughout study.	From screening to day 16
Secondary	Plasma pharmacokinetic (PK) parameter: Maximum plasma concentration (Cmax)	The maximum observed plasma concentration of HS-10518.	Day 1 (after the first dose) and Day 7-10 (after the last dose)
Secondary	PK parameter :Time of maximum observed plasma concentration (Tmax)	Time of the maximum observed plasma concentration of HS-10518.	Day 1 (after the first dose) and Day 7-10 (after the last dose)
Secondary	PK parameter: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t)	Area under the concentration-time curve from time 0 to the last quantifiable concentration of HS-10518.	Day 1 (after the first dose) and Day 7-10 (after the last dose)