Study of HS-10384 in Participants of Chinese Postmenopausal Women
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Phase Ib is consisted with 3~4 multiple ascending doses.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HS-10384 Multiple ascending doses of HS-10374 orally |
Drug: HS-10384 tablets
Multiple dosing of HS-10384 orally in a fasting state
|
| Placebo Comparator: Placebo Multiple ascending doses of HS-10374 placebo orally |
Drug: HS-10384-matched placebo tablets
Multiple dosing of HS-10384-matched placebo orally in a fasting state
|
Outcome Measures
Primary Outcome Measures
- 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 [Day 1 to Day 21]
Clinical laboratory tests include blood routine, blood biochemistry, coagulation function, urine routine, thyroid function,etc.
- 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
- Cmax [Day 1 to Day 13]
Maximum plasma concentration
- Tmax [Day 1 to Day 13]
Time to Cmax
- AUC0-24 [Day 1 to Day 13]
Area under plasma concentration-time curve from time 0 to 24 h
- Css,max [Day 14 to Day 21]
Maximum plasma concentration at steady state
- Tss,max [Day 14 to Day 21]
Time to Cmax at steady state
- Css,min [Day 14 to Day 21]
Minimum plasma concentration at steady state
- AUCss [Day 14 to Day 21]
Area under plasma concentration-time curve in one dosing interval at steady state
- RAC [Day 14 to Day 21]
Degree of accumulation after multiple doses
- Luteinizing hormone changes from baseline [Day 1 to Day 21]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subjects should fully understand the content, process and possible adverse reactions of the study, and voluntarily sign the informed consent form;
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Age between 40 and 65 years old (including the critical value);
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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.);
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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);
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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;
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Have a history of migraine within 3 months before screening;
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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;
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Within 2 weeks before screening, participants have suffered from VMS that inducing the interrupt of daily activities;
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Within 30 days before taking drug, participants have taken hormonal treatment or other therapy due to VMS;
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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.;
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Within 3 months before screening, participants have taken hormonal contraceptive;
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Participants have participated in any clinical study or taken study drugs within 3 months before screening;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University Third Hospital | Peking | Beijing | China | 100000 |
Sponsors and Collaborators
- Hansoh BioMedical R&D Company
Investigators
- Principal Investigator: Rong Li, PhD, Peking University Third Hospital
- Principal Investigator: Dongyang Liu, Peking University Third Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS-10384-102