A Study of HS-10518 in Healthy Female Participants

• Status: Not yet recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Criteria

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