The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HS-10518 in healthy adult premenopausal females in China.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
48
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.
Time frame: 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.
Time frame: 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.
Time frame: From screening to day 16
Plasma pharmacokinetic (PK) parameter: Maximum plasma concentration (Cmax)
The maximum observed plasma concentration of HS-10518.
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 of the maximum observed plasma concentration of HS-10518.
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)
Area under the concentration-time curve from time 0 to the last quantifiable concentration of HS-10518.
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Time frame: Day 1 (after the first dose) and Day 7-10 (after the last dose)