This study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of GZR33 and GZR101 in healthy adult male subjects.This study consists of Part A and Part B. Part A is a randomized, open-label, single-dose, two-sequence, two-period, cross-over design comparative study evaluating the PD and PK characteristics of GZR33 and Insulin Degludec Injection. Part B is a randomized, double-blind, placebo-controlled, multiple-dose, parallel-group design study evaluating the safety, tolerability, immunogenicity, and PK of GZR33 and GZR101.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
Administered as once daily subcutaneous dose
Administered as once daily subcutaneous dose
Administered as once daily subcutaneous dose
Study Site
Xingtai, Hebei, China
AUC0-24h
Area under the plasma concentration-time curve from time 0 to 24 hours
Time frame: From 0 to 24 hours
Incidence of adverse events (AE)
Any changes or abnormal results in the following safety variables: incidence of adverse events (AE), including but not limited to hypoglycemic reactions, injection site reactions, clinical laboratory tests, 12-lead ECG, vital signs, physical examination, and local tolerability at the injection site.
Time frame: From Predose to Day12
Cmax
Maximum plasma concentration
Time frame: From Predose to Day7
tmax
Time to reach maximum plasma concentration
Time frame: From Predose to Day7
AUC0-last
Area under the plasma concentration-time curve from time 0 to the last blood sampling time point
Time frame: From Predose to Day7
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Administered as once daily subcutaneous dose