The main purposes of this study are to determine: 1. To assess the safety and tolerability of a single subcutaneous injection of different doses of TG103 in healthy Chinese adult subjects. 2. The pharmacokinetic and pharmacodynamic characteristics of a single subcutaneous injection of different doses of TG103 in healthy Chinese adult subjects were assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
32
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time frame: Baseline through Day 28
Area under the plasma concentration versus time curve (AUC)
Area under the plasma concentration versus time curve (AUC) after administration of of TG103
Time frame: 0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648h
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) after administration of of TG103
Time frame: 0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648h
Time to maximum plasma concentration(Tmax)
Time to maximum plasma concentration(Tmax)after administration of of TG103
Time frame: 0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648hours
Half time (t1/2)
The half time of TG103 after administration are calculated.
Time frame: 0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648hours
Apparent clearance (CL/F)
To assess the apparent clearance (CL/F) after administration of TG103
Time frame: 0,0.25,1,4,6,8,12,24,36,48,60,72,96,144,192,264,336,648hours
Fasting blood glucose
Changes in Fasting blood glucose compared to baseline
Time frame: 1,2,3,4,5,7days
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2-hour postprandial blood glucose
Changes in 2-hour postprandial blood glucose compared to baseline
Time frame: 1,2,3,4,5,7days
fasting insulin
Changes in fasting insulin compared to baseline
Time frame: -1,3days
fasting glucagon
Changes in fasting glucagon compared to baseline
Time frame: -1,3days