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 range18 Years – 40 Years

SexFEMALE

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.
✕. Has never been sexually active.
✕. 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.

What they're measuring

Incidence of Adverse Events (AE) as assessed by CTCAE v4.0

Timeframe: From screening to day 21

Number of Participants with Clinically Significant Changes in Laboratory Parameters

Timeframe: From screening to day 16

Incidence of clinically significan t abnormal findings in 12-lead electrocar

Timeframe: From screening to day 16

Trial details

NCT IDNCT07264192

SponsorWest China Second University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-23

View on ClinicalTrials.gov More Infertility, Female trials

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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.
✕. Has never been sexually active.
✕. 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.

What they're measuring

Incidence of Adverse Events (AE) as assessed by CTCAE v4.0

Timeframe: From screening to day 21

Number of Participants with Clinically Significant Changes in Laboratory Parameters

Timeframe: From screening to day 16

Incidence of clinically significan t abnormal findings in 12-lead electrocar

Timeframe: From screening to day 16