To evaluate the safety, tolerability and pharmacokinetics of HEC53856 after single or multiple oral administration, as well as the food effect on the pharmacokinetics, in healthy non-elderly subjects.
This is a Phase I, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Tolerability and Pharmacokinetics of HEC53856 capsule in Healthy Adult Subjects. The study consists of three parts, single dose ascending, multiple dose ascending and food effect testing. Within each part participants will be randomized to either drug or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
116
First Hospital of Jilin University
Changchun, Jilin, China
Incidence of Adverse Events [Safety and Tolerability]
To assess the safety and tolerability by incidence of treatment-emergent adverse events after a single dose or multiple doses of HEC53856 capsule
Time frame: Up to Day 10 after last dose
AUC0-t
Area under the concentration versus time curve (AUC) from time zero to the time of the last quantifiable concentration
Time frame: Up to 96 hours after dosing
Cmax
Maximum observed plasma concentration
Time frame: Up to 96 hours after dosing
Tmax
Time of the maximum observed plasma concentration
Time frame: Up to 96 hours after dosing
T T½
Apparent terminal elimination half-life
Time frame: Up to 96 hours after dosing
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