A Study of HS-10518 in Healthy Adult Premenopausal Females in China

NCT07264192 | Completed Phase 1

• 1 other identifier: HS-10518
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (3)

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

  Assessment of safety and tolerability of multiple-dose HS- 10518 in healthy female participants in terms of the frequency, severity and causality of AEs, serious adverse events (SAEs) and AEs leading to study discontinuation.

  From screening to day 21

• Number of Participants with Clinically Significant Changes in Laboratory Parameters

  Laboratory parameters include hematology, clinical chemistry, and urinalysis. The number and percentage of participants with clinically significant changes

  From screening to day 16

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

  Incidence of any clinically significant abnormal findings in 12-lead ECG is collected throughout study

  From screening to day 16

Secondary Outcomes (3)

• Maximum plasma concentration (Cmax)

  From screening to day 16

• 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

• Time of the maximum observed plasma concentration

  From screening to day 16

Study Arms (6)

HS-10518 Dose 1

EXPERIMENTAL

Dose level 1 of HS-10518, 10 mg Q12h, orally, 14 days

Drug: HS-10518

HS-10518 Dose 2

EXPERIMENTAL

Dose leve2 of HS-10518, 20 mg QD, orally, 14 days

Drug: HS-10518

HS-10518 Dose 3

EXPERIMENTAL

Dose leve3 of HS-10518, 20 mg Q12h, orally, 14 days

Drug: HS-10518

HS-10518 Dose 4

EXPERIMENTAL

Dose leve4 of HS-10518, 40 mg QD, orally, 14 days

Drug: HS-10518

HS-10518 Dose 5

EXPERIMENTAL

Dose leve5 of HS-10518, 80 mg QD, orally, 14 days

Drug: HS-10518

Placebo

PLACEBO COMPARATOR

placebo, BID, orally, 14 days

Drug: Placebo

Interventions

HS-10518 DRUG

During the Dosing Period, four capsules of HS-10518 are administered twice daily at the same time points each day (morning and evening). The capsules should be swallowed whole with approximately 240 mL of water, and fluid intake is restricted within 1 hour before and after drug administration. Consecutive dosing should be maintained for 14 days.

HS-10518 Dose 1; HS-10518 Dose 2; HS-10518 Dose 3; HS-10518 Dose 4; HS-10518 Dose 5

Placebo DRUG

During the Dosing Period, four capsules of HS-10518 Placebo are administered twice daily at the same time points each day (morning and evening). The capsules should be swallowed whole with approximately 240 mL of water, and fluid intake is restricted within 1 hour before and after drug administration. Consecutive dosing should be maintained for 14 days.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects may be enrolled only if they meet all the following 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:
• Cycle length: 24 to 32 days;
• Menstrual period duration: 2 to 7 days;(The first day of menstruation is defined as Day 1 of the menstrual cycle.)
• 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:
• Continuous abstinence;
• Surgical sterilization of the subject (performed at least 3 months prior to signing the informed consent form);
• Surgical sterilization of the subject's sexual partner (performed at least 6 months prior to signing the informed consent form).Other dual non-hormonal contraceptive methods are also acceptable, including:
• Condoms with spermicides;
• Diaphragms with spermicides (used with or without condoms);
• Cervical caps with spermicides (used with or without condoms);

You may not qualify if:

• Subjects will be excluded from the study if they meet any one of the following 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:
• Smoking: More than 5 cigarettes per day or equivalent tobacco products;
• Alcohol abuse: Alcohol consumption of ≥14 units per week (1 unit = 285 mL of beer, 25 mL of spirits with alcohol content ≥40%, or 150 mL of wine).
• 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.
• Has a history of malignant tumors (cancer).
• Has had clinically significant gastrointestinal complaints, a history of gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis), or a history of surgery that may affect the absorption of the study drug (except for simple appendectomy or hernia repair) within 7 days prior to the first dose.
• Has a history of migraine, epilepsy, convulsions, depression, or a clinically significant depressive state.
• Has a history of thyroid or parathyroid dysfunction, or has thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), or free thyroxine (FT4) levels outside the normal reference range-except if the investigator determines that the abnormality does not affect the study.

Sponsors & Collaborators

• West China Second University Hospital: lead
• Jiangsu Hansoh Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

West China Second University Hospital

Chengdu, China

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Yu Qin

  China West China Second University Hospital Chengdu, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Office of Clinical Trial Institution

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 4, 2025
• Study Start: March 11, 2025
• Primary Completion: June 23, 2025
• Study Completion: September 9, 2025
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

CN (1)