To evaluate the safety and tolerability of single and multiple doses of SYH2069 Injection in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
A subcutaneous injection in the abdomen of the corresponding dose of SYH2069 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
after single and multiple doses
Time frame: SAD: Screening period up to day 29 MAD: Screening period up to day 50
Maximum plasma concentration (Cmax)
after single and multiple doses
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Area under the concentration-time curve from time 0 to the last measurable time point (AUClast)
after single and multiple doses
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Area under the concentration time curve from time 0 to infinity (AUCinf)
after single and multiple doses
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Percent of AUC extrapolated to infinity (AUC_Extrap)
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Time to maximum concentration (Tmax)
after single and multiple doses
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Elimination half-life (t1/2)
after single and multiple doses
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Apparent volume of distribution (Vz/F)
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after single and multiple doses
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Apparent clearance (CL/F)
after single and multiple doses
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Anti-SYH2069 antibody (ADA)
after single and multiple doses
Time frame: SAD: Pre-dose at day 1 to day 29. MAD: Pre-dose at day 1 to day 50.
Mean change in plasma glucose from baseline
after single and multiple doses
Time frame: SAD: Baseline up to Day 29 MAD: Baseline up to Day 50
Mean change in insulin from baseline
after single and multiple doses
Time frame: SAD: Baseline up to Day 29 MAD: Baseline up to Day 50
Mean change in C-peptide from baseline
after single and multiple doses
Time frame: SAD: Baseline up to Day 29 MAD: Baseline up to Day 50
Mean change in glucagon from baseline
after single and multiple doses
Time frame: SAD: Baseline up to Day 29 MAD: Baseline up to Day 50
Mean change in HbA1c from baseline
after multiple doses
Time frame: MAD: Baseline up to Day 50
Change in body weight from baseline
after multiple doses
Time frame: MAD: Baseline up to Day 50
Change in waist circumference from baseline
after multiple doses
Time frame: MAD: Baseline up to Day 50
Mean change in Total Cholesterol(TC) from baseline
after multiple doses
Time frame: MAD: Baseline up to Day 29
Mean change in Triglycerides(TG) from baseline
after multiple doses
Time frame: MAD: Baseline up to Day 29
Mean change in Low-Density Lipoprotein Cholesterol(LDLC) from baseline
after multiple doses
Time frame: MAD: Baseline up to Day 29
Mean change in High-Density Lipoprotein Cholesterol(HDLC) from baseline
after multiple doses
Time frame: MAD: Baseline up to Day 29
Change in blood pressure from baseline
after multiple doses
Time frame: MAD:Baseline up to Day 50
Change in Visceral Fat from baseline via Bioelectrical Impedance Analysis (BIA)
after multiple doses
Time frame: MAD: Baseline up to Day 29
Change in Body Fat from baseline via Bioelectrical Impedance Analysis (BIA)
after multiple doses
Time frame: MAD: Baseline up to Day 29
Change in Skeletal Muscle from baseline via Bioelectrical Impedance Analysis (BIA)
after multiple doses
Time frame: MAD: Baseline up to Day 29
Corrected QT(QTc) interval
Baseline- and placebo-corrected QTcF ( ΔΔQTcF )
Time frame: SAD: Pre-dose at day 1 to day 8 MAD: Pre-dose at day 1 to day 29