To evaluate the safety and tolerability of single dose of SYH2082 Injection in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
A subcutaneous injection in the abdomen of the corresponding dose of SYH2082 Injection according to the assigned dose cohort.
A subcutaneous injection in the abdomen of the corresponding dose of Placebo according to the assigned dose cohort.
The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Number of participants with treatment-related adverse events as accessed by CTCAE v6.0
Time frame: Screening period up to day 57
Maximum plasma concentration (Cmax)
Time frame: Pre-dose at day 1 to day 57
Area under the concentration-time curve from time 0 to the last measurable time point (AUClast)
Time frame: Pre-dose at day 1 to day 57
Area under the concentration time curve from time 0 to infinity (AUCinf)
Time frame: Pre-dose at day 1 to day 57
Percent of AUC extrapolated to infinity (AUC_Extrap)
Time frame: Pre-dose at day 1 to day 57
Time to maximum concentration (Tmax)
Time frame: Pre-dose at day 1 to day 57
Elimination half-life (t1/2)
Time frame: Pre-dose at day 1 to day 57
Apparent volume of distribution (Vz/F)
Time frame: Pre-dose at day 1 to day 57
Apparent clearance (CL/F)
Time frame: Pre-dose at day 1 to day 57
Anti-SYH2082 antibodies (ADA)
Time frame: Pre-dose at day 1 to day 57
Mean change in plasma glucose from baseline
Time frame: Baseline up to Day 57
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Mean change in insulin from baseline
Time frame: Baseline up to Day 57
Mean change in C-peptide from baseline
Time frame: Baseline up to Day 57
Mean change in glucagon from baseline
Time frame: Baseline up to Day 57
Mean change in HbA1c from baseline
Time frame: Baseline up to Day 57
Change in body weight from baseline
Time frame: Baseline up to Day 57
Change in waist circumference from baseline
Time frame: Baseline up to Day 57
Mean change in Total Cholesterol(TC) from baseline
Time frame: Baseline up to Day 57
Mean change in Triglycerides(TG) from baseline
Time frame: Baseline up to Day 57
Mean change in Low-Density Lipoprotein Cholesterol(LDLC) from baseline
Time frame: Baseline up to Day 57
Mean change in High-Density Lipoprotein Cholesterol(HDLC) from baseline
Time frame: Baseline up to Day 57
Change in blood pressure from baseline
Time frame: Baseline up to Day 57
Change in Visceral Fat from baseline via Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline up to Day 57
Change in Body Fat from baseline via Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline up to Day 57
Change in Skeletal Muscle from baseline via Bioelectrical Impedance Analysis (BIA)
Time frame: Baseline up to Day 57
Corrected QT(QTc) interval
Baseline- and placebo-corrected QTcF (ΔΔQTcF)
Time frame: Pre-dose at day 1 to day 8