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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.
Phase Ib is consisted with 3~4 multiple ascending doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-10384 | Experimental | Multiple ascending doses of HS-10384 orally |
|
| Placebo | Placebo Comparator | Multiple ascending doses of HS-10384 placebo orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-10384 tablets | Drug | Multiple dosing of HS-10384 orally in a fasting state |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration | Day 1 to Day 13 |
| Tmax | Time to Cmax | Day 1 to Day 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rong Li | Contact | (+86)010-82265571 | roseli001@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Rong Li, PhD | Peking University Third Hospital | Principal Investigator |
| Dongyang Liu | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100000 | China |
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| HS-10384-matched placebo tablets |
| Drug |
Multiple dosing of HS-10384-matched placebo orally in a fasting state |
|
| 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 |