Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
48 participants
INTERVENTIONAL
2023-11-01
2024-08-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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HS-10518 Dose 1
Dose level 1 of HS-10518, QD, orally, 7 days
HS-10518
QD, orally for 7 days
Placebo Dose 1
Dose level 1 of matching placebo, QD, orally, 7 days
Placebo
QD, orally for 7 days
HS-10518 Dose 2
Dose level 2 of HS-10518, QD, orally, 7 days
HS-10518
QD, orally for 7 days
Placebo Dose 2
Dose level 2 of matching placebo, QD, orally, 7 days
Placebo
QD, orally for 7 days
HS-10518 Dose 3
Dose level 3 of HS-10518, QD, orally, 7 days
HS-10518
QD, orally for 7 days
Placebo Dose 3
Dose level 3 of matching placebo,QD, orally, 7 days
Placebo
QD, orally for 7 days
HS-10518 Dose 4
Dose level 4 of HS-10518, QD, orally, 7 days
HS-10518
QD, orally for 7 days
Placebo Dose 4
Dose level 4 of matching placebo, QD, orally, 7 days
Placebo
QD, orally for 7 days
Interventions
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HS-10518
QD, orally for 7 days
Placebo
QD, orally for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
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Jiangsu Hansoh Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Other Identifiers
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HS-10518-101
Identifier Type: -
Identifier Source: org_study_id
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