The Safety, Tolerability Pharmacokinetic and Food Effect Study of HEC585 in Healthy Male and Female Subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Shanghai Xuhui Central Hospital
Shanghai, China
Safety and Tolerability of HEC585 by Assessment of the Number of Adverse Events (AEs) Following Administration of Oral Solution in Single Ascending Dose and Multiple Ascending Doses
To investigate the safety and tolerability of HEC585 by assessment of AEs (non-serious and serious) following administration of oral solution in SAD and MAD
Time frame: up to 18 days
PK parameters - AUC0-∞
area under the concentration versus time curve (AUC) from time zero to infinity
Time frame: up to 96 hours
PK parameters - Cmax
Geometric Mean of Maximum Observed Plasma Concentration of HEC585
Time frame: up to 96 hours
PK parameters -tmax
maximum observed plasma concentration
Time frame: up to 96 hours
PK parameters -t½
apparent terminal elimination half-life
Time frame: up to 96 hours
PK parameters -Vz/F
apparent volume of distribution
Time frame: up to 96 hours
PK parameters - MRT
the Mean Residence Time
Time frame: up to 96 hours
PK parameters -CL/F
the Apparent Clearance
Time frame: up to 96 hours
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PK parameters -R
the Accumulation Ratio
Time frame: up to 96 hours
Food Effect
Effect of Food on PK parameters of HEC585
Time frame: up to 96 hours