Primary Objective: 1. To evaluate the tolerability, safety of single and multiple doses of YZJ-1139 in healthy participants 2. To evaluate the pharmacokinetic of single and multiple doses of YZJ-1139 in healthy participants Secondary objectives: To explore the safe tolerated dose of YZJ-1139, provide data support for the design of phase II dosing regimen
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
104
Beijing Ditan Hospital Capital Medical University
Beijing, China
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 to Day 3 post single dose;From Day 1 to Day 14 post multiple dose;
Cmax of YZJ-1139
Cmax is defined as the maximum concentration of drug.
Time frame: From Day 1 to Day 2 post single dose;From Day 1 to Day 8 post multiple dose
AUCinf of YZJ-1139
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Time frame: From Day 1 to Day 2 post single dose;From Day 1 to Day 8 post multiple dose
AUClast of YZJ-1139
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time frame: From Day 1 to Day 2 post single dose;From Day 1 to Day 8 post multiple dose
AUC0-τ of YZJ-1139
AUC0-τ is defined as the area under the concentration-time curve over the dosing interval
Time frame: From Day 1 to Day 8 post multiple dose
Css,avg of YZJ-1139
Css,avg is defined as the average steady state concentration
Time frame: From Day 1 to Day 8 post multiple dose
Css,min of YZJ-1139
Css,min is defined as the minimum observed concentration at steady
Time frame: From Day 1 to Day 8 post multiple dose
Tmax of YZJ-1139
Tmax is defined as the time (observed time point) of Cmax
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Time frame: From Day 1 to Day 2 post single dose;From Day 1 to Day 8 post multiple dose
t1/2 of YZJ-1139
Time frame: From Day 1 to Day 2 post single dose;From Day 1 to Day 8 post multiple dose
CL/F of YZJ-1139
CL/F is defined as the apparent oral clearance following administration of the drug
Time frame: From Day 1 to Day 2 post single dose;From Day 1 to Day 8 post multiple dose
Vz/F of YZJ-1139
Vz/F is defined as the apparent volume of distribution of the drug
Time frame: From Day 1 to Day 2 post single dose;From Day 1 to Day 8 post multiple dose
Rac of YZJ-1139
Rac is defined as the accumulation Ratio
Time frame: From Day 1 to Day 8 post multiple dose