The aim of the trial is to investigate the the bioavailability, pharmacokinetics, pharmacodynamics, safety and tolerance of single and multiple doses of GZR18 tablet in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Oral administered the GZR18 tablet
Study Site 01
Beijing, China
AE and SAE
Incidence of Adverse Events and Severe Adverse Events
Time frame: 22 days and 35 days
Relative bioavailability of GZR18 tablet
Fr =AUC0-t(GZR18 tablets)/AUC0-t(GZR18 injection)×100%
Time frame: 22 days and 35 days
ADA and NAb
Anti-Drug Antibody (ADA) and Neutralizing Antibody (Nab)
Time frame: 22 days and 35 days
Cmax
Maximum plasma drug concentration
Time frame: 22 days and 35 days
AUC0-t
Area under the curve from 0 through the time of the last accurately measurable concentration
Time frame: 22 days and 35 days
AUC0-24h
Area under the curve from 0 h to 24 hours
Time frame: 22 days and 35 days
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