A Phase I, Single Center, Randomized, Double-blind, Placebo-controlled, Single \& Multiple Ascending Dose Study to Access the Tolerability and Pharmacokinetics of HEC110114 Tablets in Healthy Adult Subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
93
administered orally once daily
Placebo will be administered orally at a dose and frequency matched to HEC110114
The First Hospital of Jilin University
Changchun, Jilin, China
Adverse Events
Percentage of Participants with Adverse Events
Time frame: From Days 1-12
Cmax
Maximum Observed Plasma Concentration
Time frame: At pre-defined intervals from Days 1-12
Tmax
Time to Maximum Observed Plasma Concentration
Time frame: At pre-defined intervals from Days 1-12
AUClast
Area Under the Plasma Concentration vs Time Curve to Last Measurable Concentration
Time frame: At pre-defined intervals from Days 1-12
AUC0-∞
Area Under the Plasma Concentration vs Time Curve Extrapolated to Infinity
Time frame: At pre-defined intervals from Days 1-12
T1/2
Apparent Half-Life
Time frame: At pre-defined intervals from Days 1-12
CL/F
Clearance (CL/F) of HEC110114
Time frame: At pre-defined intervals from Days 1-12
Cmin
Trough Plasma Concentration of HEC110114
Time frame: At pre-defined intervals from Days 1-11 for MAD
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