A Study of HS-10518 in Healthy Adult Premenopausal Females in China (NCT07264192) | Clinical Trial Compass
CompletedPhase 1
A Study of HS-10518 in Healthy Adult Premenopausal Females in China
China60 participantsStarted 2025-03-11
Plain-language 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
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At the time of signing the informed consent form, the subject must be 18 to 40 years old (inclusive).
. Confirmed to be a healthy subject through medical assessment, including indicators such as medical history, physical examination, laboratory tests, and 12-lead electrocardiogram (ECG).
. Regular menstrual cycles for at least 6 months prior to screening, with:
. Baseline sex hormone levels meet the following requirements: Follicle-Stimulating Hormone (FSH) \< 10 IU/L and Estradiol (E2) \< 100 pg/mL; in addition, other sex hormone indicators must be assessed by the investigator as normal for the subject to be randomly enrolled.
. Body weight ≥ 45 kg, and Body Mass Index (BMI) within the range of 18 to 28 kg/m² (inclusive).
. The subject agrees to use highly effective non-hormonal contraceptive methods from the date of signing the informed consent form until 3 months after the administration of the last dose of the study drug. Highly effective non-hormonal contraceptive methods include:
. Have a full understanding of the study content, process, and potential adverse reactions, and voluntarily sign the informed consent form.
Exclusion criteria
. Has a history of abnormal uterine bleeding within 3 months prior to screening.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events (AE) as assessed by CTCAE v4.0
Timeframe: From screening to day 21
2
Number of Participants with Clinically Significant Changes in Laboratory Parameters
Timeframe: From screening to day 16
3
Incidence of clinically significan t abnormal findings in 12-lead electrocar
. Has consumed foods or beverages rich in caffeine and/or xanthine (e.g., coffee, tea, chocolate, caffeinated carbonated beverages such as cola), tobacco-containing products (e.g., cigarettes), alcohol, or alcohol-containing products within 48 hours prior to drug administration.
. Has consumed grapefruit, grapefruit juice, bitter orange, bitter orange marmalade, bitter orange juice, or other products containing grapefruit or bitter orange within 7 days prior to the first dose.
. Has a history of smoking or alcohol abuse within 6 months prior to screening:
. Is suspected of substance abuse involving barbiturates, amphetamines, benzodiazepines, cocaine, opioids, cannabis, methadone, phencyclidine (PCP), tricyclic antidepressants (TCAs), or methamphetamine.
. Has a positive alcohol breath test or positive urine drug abuse screening result.
. Is pregnant, lactating, or has a positive serum beta-human chorionic gonadotropin (β-hCG) test at screening.