Infertility, FemalePhase 1NCT07264192
A Study of HS-10518 in Healthy Adult Premenopausal Females in China
A Phase 1 study testing HS-10518 in people with Infertility, Female, run by West China Second University Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- HS-10518
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 11 Mar 2025to 9 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.)
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- 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);
- Vaginal sponges with spermicides (used together with condoms).
- Have a full understanding of the study content, process, and potential adverse reactions, and voluntarily sign the informed consent form.
Who cannot join
- 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:
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- 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.
- Is within 6 months after childbirth, abortion, or cessation of lactation.
- Has a history of severe drug hypersensitivity, allergic diseases (e.g., asthma, urticaria, allergic rhinitis), or a history of atopy (allergic to ≥2 allergens)-if the investigator determines that the subject is unsuitable for the study.
- Has donated blood, lost ≥400 mL of blood, or received a blood transfusion within 3 months prior to screening; or has donated blood or lost ≥200 mL of blood within 1 month prior to screening.
- Has used any medications (prescription drugs, over-the-counter (OTC) drugs, traditional Chinese medicines, dietary supplements including vitamins, etc.) or short-term topical medications within 4 weeks prior to the first dose (or at least 5 times the respective elimination half-life, whichever is longer)-except if the investigator determines that the use does not affect the study.
- Has positive results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV), or syphilis serological test (TRUST)/treponema pallidum antibody (TP-Ab) at screening-except for subjects judged by the investigator to have a history of syphilis but have been cured.
- Has alanine transaminase (ALT) or aspartate transaminase (AST) levels exceeding the upper limit of normal (ULN) at screening.
- Has serum creatinine > 1.5 × ULN, or an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m² (calculated using the Modification of Diet in Renal Disease (MDRD) formula) at screening.
- Has abnormal and clinically significant electrocardiogram (ECG) findings at screening (e.g., absolute value of QTcF [QT interval corrected by Fridericia's formula: QT/RR⁰·³³] > 470 milliseconds [ms]).
- Has diseases related to the ovaries, breasts, uterus, hypothalamus, or pituitary gland-if the investigator determines that the subject is unsuitable for the study.
- Has sonographic evidence of physiological abnormalities in the uterus and bilateral ovaries-if the investigator determines that the subject is unsuitable for the study.
- Has abnormal and clinically significant results from a cervical ThinPrep cytology test (TCT) during screening or within the past 12 months; for subjects with TCT results of "atypical squamous cells of undetermined significance (ASC-US)", enrollment is permitted only if high-risk human papillomavirus (HPV) testing is negative.
- Has recently used prohibited medications:
- Used short-acting preparations containing sex hormones or affecting sex hormone levels (oral, transdermal, intravaginal, etc.) within 3 months prior to the first dose;
- Used long-acting preparations containing sex hormones or affecting sex hormone levels (any long-acting injections or implants) within 6 months prior to the first dose.
- Plans to become pregnant during the study or within 3 months after the study ends.
- Participated in other clinical drug trials within 3 months prior to screening.
- Has other conditions or reasons deemed by the investigator to make the subject unsuitable for participation in the clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10518 in Healthy Adult Premenopausal Females in China
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HS-10518 in healthy adult premenopausal females in China
Read the detailed description
In this randomized, double-blind, placebo-controlled Phase I clinical trial, 60 participants were randomized in a 1:1:1:1:1:1 ratio to receive HS-10518 (10 mg Q12h, 20 mg QD, 20 mg Q12h, 40 mg QD, or 80 mg QD) or placebo for 14 consecutive days. Assessments included safety, tolerability, PK parameters, and PD parameters.
- Conditions
- Infertility, Female
- Being tested
- HS-10518, Placebo
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10518Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| HS-10518 Dose 1 | Experimental | Dose level 1 of HS-10518, 10 mg Q12h, orally, 14 days Receives: Drug: HS-10518 |
| HS-10518 Dose 2 | Experimental | Dose leve2 of HS-10518, 20 mg QD, orally, 14 days Receives: Drug: HS-10518 |
| HS-10518 Dose 3 | Experimental | Dose leve3 of HS-10518, 20 mg Q12h, orally, 14 days Receives: Drug: HS-10518 |
| HS-10518 Dose 4 | Experimental | Dose leve4 of HS-10518, 40 mg QD, orally, 14 days Receives: Drug: HS-10518 |
| HS-10518 Dose 5 | Experimental | Dose leve5 of HS-10518, 80 mg QD, orally, 14 days Receives: Drug: HS-10518 |
| Placebo | Placebo comparator | placebo, BID, orally, 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: From screening to day 16
Secondary outcomes (3)
Maximum plasma concentration (Cmax)
The maximum observed plasma concentration of HS-10518
Measured: From screening to day 16
Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t)
Laboratory parameters include hematology, clinical chemistry, and urinalysis. The number and percentage of participants with clinically significant changes from baseline at each post-baseline visit will be summarized
Measured: Area under the concentration-time curve from time 0 to the last quantifiable concentration of HS-10518
Time of the maximum observed plasma concentration
Time of the maximum observed plasma concentration of HS- 10518
Measured: From screening to day 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start11 Mar 2025
- Primary completion23 Jun 2025
- Study completion9 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Yu Qin, West China Second University Hospital
- Investigators
- Yu Qin, Principal investigator, China West China Second University Hospital Chengdu, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264192
- Sponsor's protocol ID
- HS-10518
- Status last verified
- Mar 2026
- First submitted
- 16 Nov 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HS-10518 in Healthy Adult Premenopausal Females in China
- ClinicalTrials.gov ID
- NCT07264192
- Acronym / sponsor ID
- HS-10518
- Conditions
- Infertility, Female
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 23 Jun 2025 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
In this randomized, double-blind, placebo-controlled Phase I clinical trial, 60 participants were randomized in a 1:1:1:1:1:1 ratio to receive HS-10518 (10 mg Q12h, 20 mg QD, 20 mg Q12h, 40 mg QD, or 80 mg QD) or placebo for 14 consecutive days. Assessments included safety, tolerability, PK parameters, and PD parameters.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| HS-10518 Dose 1 | Experimental | Drug: HS-10518Dose level 1 of HS-10518, 10 mg Q12h, orally, 14 days |
| HS-10518 Dose 2 | Experimental | Drug: HS-10518Dose leve2 of HS-10518, 20 mg QD, orally, 14 days |
| HS-10518 Dose 3 | Experimental | Drug: HS-10518Dose leve3 of HS-10518, 20 mg Q12h, orally, 14 days |
| HS-10518 Dose 4 | Experimental | Drug: HS-10518Dose leve4 of HS-10518, 40 mg QD, orally, 14 days |
| HS-10518 Dose 5 | Experimental | Drug: HS-10518Dose leve5 of HS-10518, 80 mg QD, orally, 14 days |
| Placebo | Placebo comparator | Drug: Placeboplacebo, BID, orally, 14 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- Subjects may be enrolled only if they meet all the following criteria:
Key exclusion criteria (32 listed)
- Subjects will be excluded from the study if they meet any one of the following criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10518During 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. | Drug | HS-10518 Dose 1, HS-10518 Dose 2, HS-10518 Dose 3, HS-10518 Dose 4, HS-10518 Dose 5 |
| PlaceboDuring 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. | Drug | Placebo |
Primary outcome
Incidence of Adverse Events (AE) as assessed by CTCAE v4.0
Time frame: From screening to day 21
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.
Number of Participants with Clinically Significant Changes in Laboratory Parameters
Time frame: From screening to day 16
Laboratory parameters include hematology, clinical chemistry, and urinalysis. The number and percentage of participants with clinically significant changes
Incidence of clinically significan t abnormal findings in 12-lead electrocar
Time frame: From screening to day 16
Incidence of any clinically significant abnormal findings in 12-lead ECG is collected throughout study
3 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: From screening to day 16
Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t)
Time frame: Area under the concentration-time curve from time 0 to the last quantifiable concentration of HS-10518
Time of the maximum observed plasma concentration
Time frame: From screening to day 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Qin principal investigator
China West China Second University Hospital Chengdu, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10518 in people with Infertility, Female, run by West China Second University Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AE) as assessed by CTCAE v4.0 (time frame: From screening to day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.