Clinical trial NCT06118827: A Study of HS-10518 in Healthy Female Participants
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Endometriosis
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

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

Primary outcomes:
measure: Incidence of Adverse Events (AE) as assessed by CTCAE v4.0
timeFrame: From screening to day 16
measure: 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.
timeFrame: From screening to day 16
measure: Incidence of clinically significant abnormal findings in 12-lead electrocardiogram (ECG)
timeFrame: From screening to day 16
Secondary outcomes:
measure: Plasma pharmacokinetic (PK) parameter: Maximum plasma concentration (Cmax)
timeFrame: Day 1 (after the first dose) and Day 7-10 (after the last dose)
measure: PK parameter :Time of maximum observed plasma concentration (Tmax)
timeFrame: Day 1 (after the first dose) and Day 7-10 (after the last dose)
measure: PK parameter: Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t)
timeFrame: Day 1 (after the first dose) and Day 7-10 (after the last dose)
Other outcomes:
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