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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Multiple dosing of HS-10384 orally in a fasting state
Multiple dosing of HS-10384-matched placebo orally in a fasting state
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe 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 clinical laboratory abnormalities
Clinical laboratory tests include blood routine, blood biochemistry, coagulation function, urine routine, thyroid function,etc.
Time frame: Day 1 to Day 21
Number of participants with abnormalities of vital signs
Time frame: Day 1 to Day 21
Number of participants with abnormalities of physical examination
Time frame: Day 1 to Day 21
Cmax
Maximum plasma concentration
Time frame: Day 1 to Day 13
Tmax
Time to Cmax
Time frame: Day 1 to Day 13
AUC0-24
Area under plasma concentration-time curve from time 0 to 24 h
Time frame: Day 1 to Day 13
Css,max
Maximum plasma concentration at steady state
Time frame: Day 14 to Day 21
Tss,max
Time to Cmax at steady state
Time frame: Day 14 to Day 21
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Css,min
Minimum plasma concentration at steady state
Time frame: Day 14 to Day 21
AUCss
Area under plasma concentration-time curve in one dosing interval at steady state
Time frame: Day 14 to Day 21
RAC
Degree of accumulation after multiple doses
Time frame: Day 14 to Day 21
Luteinizing hormone changes from baseline
Time frame: Day 1 to Day 21