This is a randomized, double-blind, placebo-controlled, single dose phase I clinical study. It is divided into two parts: part A , a single ascending dose assessment of GZR33, and partB, a single dose evaluation of GZR101.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
52
Study Site 01
Tianjin, China
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 Day14 after a single dose
GIRmax
Maximum glucose infusion rate
Time frame: From 0 hours to 24 hours after a single dose
AUCGZR33,0-24 h
Area under the plasma concentration curve of GZR33 from 0 to 24 hours
Time frame: From Predose to Day8 after a single dose
AUCIAsp,0-12 h
Area under the plasma concentration curve of insulin aspart from 0 to 12 hours
Time frame: From 0 hours to 12 hours after a single dose
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