Study of HS-10384 in Participants of Chinese Postmenopausal Women

Phase 1

Recruiting

• Conditions: Vasomotor Symptoms
• Interventions: Drug: HS-10384 tablets; Drug: HS-10384-matched placebo tablets

• Registration Number: NCT06122181
• Lead Sponsor: Hansoh BioMedical R&D Company

Brief Summary

A randomized, double-blind, placebo-controlled phase Ib clinical study to evaluate the safety, tolerability and pharmacokinetics characteristics of HS-10384 in Chinese postmenopausal women.

Detailed Description

Phase Ib is consisted with 3\~4 multiple ascending doses.

Study Timeline

• Study First Submitted: 2023-11-03
• Study First Submitted QC: 2023-11-07
• Study First Posted: 2023-11-08
• Study Start: 2023-11-12
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-13
• Primary Completion: 2024-06-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 48

Inclusion Criteria

1. Subjects should fully understand the content, process and possible adverse reactions of the study, and voluntarily sign the informed consent form;
2. Age between 40 and 65 years old (including the critical value);
3. The body mass index (BMI=body weight [kg]/height2 [m2]) at screening is 19~28 kg/m2 (including the critical value of 19), and the weight is ≥ 40 kg;
4. Subjects are postmenopausal women at screening as qualified by any of the following criteria: spontaneous amenorrhea ≥ 12 months, or spontaneous amenorrhea ≥ 6 months and FSH>40 IU/L (without other obvious pathological or physiological reasonsbefore screening), or documented surgical sterilization (such as hysterectomy, bilateral salpingectomy or bilateral oophorectomy, etc.);
5. From 48 hours before taking drug to the end of the study, subjects should avoid taking tobacco products, alcohol and other foods or drinks that might affect drug metabolism (such as coffee, tea, cola or other caffeinated drinks);
6. The blood pregnancy test of female subjects at baseline period is negative.

Exclusion Criteria

1. Participants with disease history of uterine bleeding, uterine ovarian tumor, pituitary tumor, or other diseases evaluated by the principal investigator as not suitable for this study;
2. Have a history of migraine within 3 months before screening;
3. Participants with clinically significant diseases (such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, endocrine and metabolic system, blood system, skin disease, immune system, tumor, etc.) were evaluated by the researcher as not suitable for this study;
4. Within 2 weeks before screening, participants have suffered from VMS that inducing the interrupt of daily activities;
5. Within 30 days before taking drug, participants have taken hormonal treatment or other therapy due to VMS;
6. Within 4 weeks or 5 half-lives (whichever is longer) before screening, and during the whole study period, it is expected to take any medicine and health care products, including prescription drugs, immunomodulator or Chinese herbal medicine, etc.;
7. Within 3 months before screening, participants have taken hormonal contraceptive;
8. Participants have participated in any clinical study or taken study drugs within 3 months before screening;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HS-10384	HS-10384 tablets	Multiple ascending doses of HS-10384 orally
Placebo	HS-10384-matched placebo tablets	Multiple ascending doses of HS-10384 placebo orally

Primary Outcome Measures

Name	Time	Method
Number of participants with abnormalities of vital signs	Day 1 to Day 21
Number of participants with clinical laboratory abnormalities	Day 1 to Day 21	Clinical laboratory tests include blood routine, blood biochemistry, coagulation function, urine routine, thyroid function,etc.
The incidence and severity of adverse events (AE), serious adverse events (SAE) and adverse events leading to withdrawal from the trial and the correlation with the investigational drug;	Day 1 to Day 21
Number of participants with abnormalities of physical examination	Day 1 to Day 21

Secondary Outcome Measures

Name	Time	Method
Cmax	Day 1 to Day 13	Maximum plasma concentration
Tss,max	Day 14 to Day 21	Time to Cmax at steady state
Css,max	Day 14 to Day 21	Maximum plasma concentration at steady state
AUCss	Day 14 to Day 21	Area under plasma concentration-time curve in one dosing interval at steady state
Tmax	Day 1 to Day 13	Time to Cmax
Css,min	Day 14 to Day 21	Minimum plasma concentration at steady state
RAC	Day 14 to Day 21	Degree of accumulation after multiple doses
AUC0-24	Day 1 to Day 13	Area under plasma concentration-time curve from time 0 to 24 h
Luteinizing hormone changes from baseline	Day 1 to Day 21

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Peking, Beijing, China