A Study of HS-10518 in Healthy Female Participants

NCT06118827 | Unknown Phase 1

• 1 other identifier: HS-10518-101
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From screening to day 16

Secondary Outcomes (3)

• Plasma pharmacokinetic (PK) parameter: Maximum plasma concentration (Cmax)

  Day 1 (after the first dose) and Day 7-10 (after the last dose)

• PK parameter :Time of maximum observed plasma concentration (Tmax)

  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)

  Day 1 (after the first dose) and Day 7-10 (after the last dose)

Study Arms (8)

HS-10518 Dose 1

EXPERIMENTAL

Dose level 1 of HS-10518, QD, orally, 7 days

Drug: HS-10518

Placebo Dose 1

PLACEBO COMPARATOR

Dose level 1 of matching placebo, QD, orally, 7 days

Drug: Placebo

HS-10518 Dose 2

EXPERIMENTAL

Dose level 2 of HS-10518, QD, orally, 7 days

Drug: HS-10518

Placebo Dose 2

PLACEBO COMPARATOR

Dose level 2 of matching placebo, QD, orally, 7 days

Drug: Placebo

HS-10518 Dose 3

EXPERIMENTAL

Dose level 3 of HS-10518, QD, orally, 7 days

Drug: HS-10518

Placebo Dose 3

PLACEBO COMPARATOR

Dose level 3 of matching placebo,QD, orally, 7 days

Drug: Placebo

HS-10518 Dose 4

EXPERIMENTAL

Dose level 4 of HS-10518, QD, orally, 7 days

Drug: HS-10518

Placebo Dose 4

PLACEBO COMPARATOR

Dose level 4 of matching placebo, QD, orally, 7 days

Drug: Placebo

Interventions

HS-10518 DRUG

QD, orally for 7 days

Also known as: TU2670

HS-10518 Dose 1; HS-10518 Dose 2; HS-10518 Dose 3; HS-10518 Dose 4

Placebo DRUG

QD, orally for 7 days

Also known as: HS-10518 Placebo

Placebo Dose 1; Placebo Dose 2; Placebo Dose 3; Placebo Dose 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Endometriosis

Interventions

TU2670

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 7, 2023
• Study Start: November 1, 2023
• Primary Completion: May 30, 2024
• Study Completion: August 30, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-10