This is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical study. A sequential design is used in this trial with a single dose escalation climb test, to investigate the safety, tolerability, and PK/PD characteristics of GZR18 injection in Chinese obese/overweight subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
16
Gan & Lee Pharmaceuticals Co., Ltd
Beijing, China
TEAE
Incidence of Treatment Emergent Adverse Event(s)
Time frame: 50 days
Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)
Time frame: 50 days
Cmax
Maximum plasma drug concentration
Time frame: 50 days
AUClast
area under the curve from 0 through the time of the last accurately measurable concentration
Time frame: 50 days
AUC0-inf
area under the curve extrapolated to infinity
Time frame: 50 days
Tmax
time to maximum plasma drug concentration
Time frame: 50 days
λz
elimination rate constant
Time frame: 50 days
t1/2
half-life
Time frame: 50 days
tlag
lag time
Time frame: 50 days
CL/F
apparent clearance
Time frame: 50 days
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Vz/F
volume of distribution/F
Time frame: 50 days
AUC%extra
percent of AUC0-inf extrapolated
Time frame: 50 days
MRT
mean residence time
Time frame: 50 days
Weight
Time frame: 50 days
Body Mass Index (BMI)
Time frame: 50 days