Clinical trial
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
Name
HS-10518-101
Description
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HS-10518 in healthy adult premenopausal females in China.
Trial arms
Trial start
2023-11-01
Estimated PCD
2024-05-30
Trial end
2024-08-30
Status
Not yet recruiting
Phase
Early phase I
Treatment
HS-10518
QD, orally for 7 days
Arms:
HS-10518 Dose 1, HS-10518 Dose 2, HS-10518 Dose 3, HS-10518 Dose 4
Other names:
TU2670
Placebo
QD, orally for 7 days
Arms:
Placebo Dose 1, Placebo Dose 2, Placebo Dose 3, Placebo Dose 4
Other names:
HS-10518 Placebo
Size
48
Primary endpoint
Incidence of Adverse Events (AE) as assessed by CTCAE v4.0
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.
From screening to day 16
Incidence of clinically significant abnormal findings in 12-lead electrocardiogram (ECG)
From screening to day 16
Eligibility criteria
Inclusion Criteria:
* • 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.
Exclusion Criteria:
* • 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 48, 'type': 'ESTIMATED'}}
Updated at
2023-11-07
1 organization
2 products
1 indication
Organization
Jiangsu Hansoh PharmaceuticalProduct
HS-10518Indication
EndometriosisProduct
Placebo