Status:
UNKNOWN
A Study of HS-10518 in Healthy Female Participants
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
Endometriosis
Eligibility:
FEMALE
18-45 years
Phase:
PHASE1
Brief 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
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 p...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06118827
Start Date
November 1 2023
End Date
August 30 2024
Last Update
November 7 2023
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