This trial is conducted in China. The aim of the trial is to evaluate the safety and tolerability of GZR18 injection in healthy subjects following single dose and once-weekly dose for 2 consecutive weeks until reaching the target dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
57
Gan & Lee Pharmaceuticals Co., Ltd
Beijing, China
TEAE
Incidence of treatment-emergent adverse events (TEAE)
Time frame: after 28/35 days of treatment
Cmax
The peak concentration after reaching the target dose
Time frame: 28/35 days
AUClast
the area under the concentration-time curve from 0 to the last time that the concentration can be accurately measured
Time frame: 28/35 days
AUC0-inf
the area under the concentration-time curve from 0 to infinity
Time frame: 28/35 days
Tmax
the peak time
Time frame: 28/35 days
λz
the elimination rate constant
Time frame: 28/35 days
t1/2
the half-life
Time frame: 28/35 days
tlag
retention time
Time frame: 28/35 days
CL/F
apparent clearance rate
Time frame: 28/35 days
Vz/F
apparent volume of distribution
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Time frame: 28/35 days
AUC%extra
extrapolation percentage of AUC0-in
Time frame: 28/35 days
MRT
average retention time
Time frame: 28/35 days
AUCglucose0-14h
area under the concentration-time curve of fasting blood glucose from 0 to 14 hours after each administration
Time frame: 28/35 days
AUCc-peptide0-14h
area under the concentration-time curve of fasting C-peptide from 0 to 14 hours after each administration
Time frame: 28/35 days
AUCinsulin0-14h
area under the concentration-time curve of fasting insulin from 0 to 14 hours after each administration
Time frame: 28/35 days
body weight
Time frame: 28/35 days
body mass index (BMI)
Time frame: 28/35 days