NCT06122181
Recruiting
Phase 1
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
Hansoh BioMedical R&D Company1 site in 1 country48 target enrollmentNovember 12, 2023
ConditionsVasomotor Symptoms
Overview
- Phase
- Phase 1
- Intervention
- HS-10384 tablets
- Conditions
- Vasomotor Symptoms
- Sponsor
- Hansoh BioMedical R&D Company
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Number of participants with abnormalities of vital signs
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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;
Arms & Interventions
HS-10384
Multiple ascending doses of HS-10384 orally
Intervention: HS-10384 tablets
Placebo
Multiple ascending doses of HS-10384 placebo orally
Intervention: HS-10384-matched placebo tablets
Outcomes
Primary Outcomes
Number of participants with abnormalities of vital signs
Time Frame: Day 1 to Day 21
Number of participants with clinical laboratory abnormalities
Time Frame: 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;
Time Frame: Day 1 to Day 21
Number of participants with abnormalities of physical examination
Time Frame: Day 1 to Day 21
Secondary Outcomes
- Cmax(Day 1 to Day 13)
- Tss,max(Day 14 to Day 21)
- Css,max(Day 14 to Day 21)
- AUCss(Day 14 to Day 21)
- Tmax(Day 1 to Day 13)
- Css,min(Day 14 to Day 21)
- RAC(Day 14 to Day 21)
- AUC0-24(Day 1 to Day 13)
- Luteinizing hormone changes from baseline(Day 1 to Day 21)
Study Sites (1)
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