Study of HS-10384 in Participants of Chinese Postmenopausal Women

Study Overview
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Brief Summary
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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
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Phase Ib is consisted with 3 4 multiple ascending doses.

Official Title
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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

Conditions
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Vasomotor Symptoms

Intervention / Treatment
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* Drug: HS-10384 tablets
* Drug: HS-10384-matched placebo tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects should fully understand the content, process and possible adverse reactions of the study, and voluntarily sign the informed consent form; Age between 40 and 65 years old (including the critical value); 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; 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.); 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); The blood pregnancy test of female subjects at baseline period is negative. Exclusion Criteria: 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; Have a history of migraine within 3 months before screening; 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; Within 2 weeks before screening, participants have suffered from VMS that inducing the interrupt of daily activities; Within 30 days before taking drug, participants have taken hormonal treatment or other therapy due to VMS; 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.; Within 3 months before screening, participants have taken hormonal contraceptive; Participants have participated in any clinical study or taken study drugs within 3 months before screening;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HS-10384<br>Multiple ascending doses of HS-10374 orally | Drug: HS-10384 tablets<br>* Multiple dosing of HS-10384 orally in a fasting state<br>|
| Placebo Comparator: Placebo<br>Multiple ascending doses of HS-10374 placebo orally | Drug: HS-10384-matched placebo tablets<br>* Multiple dosing of HS-10384-matched placebo orally in a fasting state<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 clinical laboratory abnormalities | Clinical laboratory tests include blood routine, blood biochemistry, coagulation function, urine routine, thyroid function,etc. | Day 1 to Day 21 | 
| Number of participants with abnormalities of vital signs |  | Day 1 to Day 21 | 
| Number of participants with abnormalities of physical examination |  | Day 1 to Day 21 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HS-10384, multiple ascending dose, postmenopausal women