EndometriosisPhase 1NCT06118827
A Study of HS-10518 in Healthy Female Participants
A Phase 1 study testing HS-10518 in people with Endometriosis, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
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 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis
- 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
- 48 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 30 Aug 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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.
Who cannot join
- • 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
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses 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
This is a double-blind, placebo-controlled, multiple-dose, single-center phase 1 study in Chinese healthy premenopausal females aged 18-45 years with a regular menstrual cycle (26-32 days). The main purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HS-10518, a gonadotropin-releasing hormone antagonist.
About 48 eligible female subjects will be enrolled. The study contains four cohorts.
In each cohort, participants will be randomly assigned to the HS-10518 arm or the placebo arm in a 3:1 ratio. HS-10518/matching placebo will be administered from Day 1 to Day 7. The study duration of each participant is up to ~10 weeks.
- Conditions
- Endometriosis
- Being tested
- HS-10518, Placebo
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10518Drug
Also called TU2670
QD, orally for 7 days
PlaceboDrug
Also called HS-10518 Placebo
QD, orally for 7 days
| Study group | Role | What they receive |
|---|---|---|
| HS-10518 Dose 1 | Experimental | Dose level 1 of HS-10518, QD, orally, 7 days Receives: Drug: HS-10518 |
| Placebo Dose 1 | Placebo comparator | Dose level 1 of matching placebo, QD, orally, 7 days Receives: Drug: Placebo |
| HS-10518 Dose 2 | Experimental | Dose level 2 of HS-10518, QD, orally, 7 days Receives: Drug: HS-10518 |
| Placebo Dose 2 | Placebo comparator | Dose level 2 of matching placebo, QD, orally, 7 days Receives: Drug: Placebo |
| HS-10518 Dose 3 | Experimental | Dose level 3 of HS-10518, QD, orally, 7 days Receives: Drug: HS-10518 |
| Placebo Dose 3 | Placebo comparator | Dose level 3 of matching placebo,QD, orally, 7 days Receives: Drug: Placebo |
| HS-10518 Dose 4 | Experimental | Dose level 4 of HS-10518, QD, orally, 7 days Receives: Drug: HS-10518 |
| Placebo Dose 4 | Placebo comparator | Dose level 4 of matching placebo, QD, orally, 7 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 subjects in terms of the frequency, severity and causality of AEs, serious adverse events (SAEs) and AEs leading to study discontinuation. CTCAE v4.0 will be used for classification and severity determination.
Measured: From screening to day 16
Assessment of safety and tolerability of HS-10518 in terms of the frequency, severity and causality of AEs, serious adverse events (SAEs) and AEs leading to study discontinuation.
Incidence of any markedly abnormal standard vital sign measurements is collected throughout study.
Measured: From screening to day 16
Incidence of clinically significant abnormal findings in 12-lead electrocardiogram (ECG)
Incidence of any clinically significant abnormal findings in 12-lead ECG is collected throughout study.
Measured: From screening to day 16
Secondary outcomes (3)
Plasma pharmacokinetic (PK) parameter: Maximum plasma concentration (Cmax)
The maximum observed plasma concentration of HS-10518.
Measured: Day 1 (after the first dose) and Day 7-10 (after the last dose)
PK parameter :Time of maximum observed plasma concentration (Tmax)
Time of the maximum observed plasma concentration of HS-10518.
Measured: Day 1 (after the first dose) and Day 7-10 (after the last dose)
PK parameter: 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.
Measured: Day 1 (after the first dose) and Day 7-10 (after the last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Nov 2023 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118827
- Sponsor's protocol ID
- HS-10518-101
- Status last verified
- Oct 2023
- First submitted
- 24 Oct 2023
- Last updated
- 7 Nov 2023
- 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 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HS-10518 in Healthy Adult Premenopausal Females in China
- ClinicalTrials.gov ID
- NCT06118827
- Acronym / sponsor ID
- HS-10518-101
- Conditions
- Endometriosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 7 Nov 2023 (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
This is a double-blind, placebo-controlled, multiple-dose, single-center phase 1 study in Chinese healthy premenopausal females aged 18-45 years with a regular menstrual cycle (26-32 days). The main purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HS-10518, a gonadotropin-releasing hormone antagonist.
About 48 eligible female subjects will be enrolled. The study contains four cohorts.
In each cohort, participants will be randomly assigned to the HS-10518 arm or the placebo arm in a 3:1 ratio. HS-10518/matching placebo will be administered from Day 1 to Day 7. The study duration of each participant is up to ~10 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| HS-10518 Dose 1 | Experimental | Drug: HS-10518Dose level 1 of HS-10518, QD, orally, 7 days |
| Placebo Dose 1 | Placebo comparator | Drug: PlaceboDose level 1 of matching placebo, QD, orally, 7 days |
| HS-10518 Dose 2 | Experimental | Drug: HS-10518Dose level 2 of HS-10518, QD, orally, 7 days |
| Placebo Dose 2 | Placebo comparator | Drug: PlaceboDose level 2 of matching placebo, QD, orally, 7 days |
| HS-10518 Dose 3 | Experimental | Drug: HS-10518Dose level 3 of HS-10518, QD, orally, 7 days |
| Placebo Dose 3 | Placebo comparator | Drug: PlaceboDose level 3 of matching placebo,QD, orally, 7 days |
| HS-10518 Dose 4 | Experimental | Drug: HS-10518Dose level 4 of HS-10518, QD, orally, 7 days |
| Placebo Dose 4 | Placebo comparator | Drug: PlaceboDose level 4 of matching placebo, QD, orally, 7 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Subject is a healthy premenopausal female aged 18-45 (inclusive) at Screening;
Key exclusion criteria (6 listed)
- • 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;
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-10518Also: TU2670QD, orally for 7 days | Drug | HS-10518 Dose 1, HS-10518 Dose 2, HS-10518 Dose 3, HS-10518 Dose 4 |
| PlaceboAlso: HS-10518 PlaceboQD, orally for 7 days | Drug | Placebo Dose 1, Placebo Dose 2, Placebo Dose 3, Placebo Dose 4 |
Primary outcome
Incidence of Adverse Events (AE) as assessed by CTCAE v4.0
Time frame: From screening to day 16
Assessment of safety and tolerability of multiple-dose HS-10518 in healthy female subjects in terms of the frequency, severity and causality of AEs, serious adverse events (SAEs) and AEs leading to study discontinuation. CTCAE v4.0 will be used for classification and severity determination.
Assessment of safety and tolerability of HS-10518 in terms of the frequency, severity and causality of AEs, serious adverse events (SAEs) and AEs leading to study discontinuation.
Time frame: From screening to day 16
Incidence of any markedly abnormal standard vital sign measurements is collected throughout study.
Incidence of clinically significant abnormal findings in 12-lead electrocardiogram (ECG)
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
Plasma pharmacokinetic (PK) parameter: Maximum plasma concentration (Cmax)
Time frame: Day 1 (after the first dose) and Day 7-10 (after the last dose)
PK parameter :Time of maximum observed plasma concentration (Tmax)
Time frame: Day 1 (after the first dose) and Day 7-10 (after the last dose)
PK parameter: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t)
Time frame: Day 1 (after the first dose) and Day 7-10 (after the last dose)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10518 in people with Endometriosis, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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 16). 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 7 Nov 2023.