This study is a safety, tolerability, and pharmacokinetics phase Ⅰstudy of HEC96719, in healthy subjects.This study is the healthy adult subjects single ascending-dose research
This study will evaluate the safety and tolerability of escalating single oral doses of HEC96719, and characterize the single-dose pharmacokinetics (PK) of HEC96719. Participants will receive either HEC96719 or HEC96719 placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
0.1、0.2、0.5、1、2、3、4 mg HEC96719 tablet in day1
0.1、0.2、0.5、1、2、3、4 mg Placebo tablet in day1
The Shanghai xuhui district central hospital
Shanghai, Shanghai Municipality, China
Adverse events of the single ascending-dose
To assess the safe and tolerability of the single ascending-dose
Time frame: From the baseline to day7
Cmax
Maximum Plasma Concentration(Cmax)of HEC96719 in single ascending dose
Time frame: At pre-defined intervals from Days 1-2
AUC
Area Under the Curve(AUC) of HEC96719 in single ascending dose
Time frame: At pre-defined intervals from Days 1-2
Tmax
Maximum Peak Time(Tmax) of HEC96719 in single ascending dose
Time frame: At pre-defined intervals from Days 1-2
T1/2
Terminal elimination half-life(T1/2) of HEC96719 in single ascending dose
Time frame: At pre-defined intervals from Days 1-2
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