To evaluate the safety and tolerability of single dose of SYH2082 Injection in healthy participants.
Fully understands the content, procedures, and possible adverse reactions of the study, and voluntarily signs the ICF before the study;
At screening, age 18-65 years (inclusive, at the time of signing the ICF), male or female;
At screening, body weight ≥50 kg for males and ≥45 kg for females; body mass index (BMI) between 22.0 and 40.0 kg/m2 (inclusive);
Body weight change ≤5% within 3 months prior to screening (including the screening period);
Known or suspected allergy to glucagon-like peptide-1 (GLP-1) or Glucose dependent insulinotropic polypeptide (GIP) receptor agonists or any component of the investigational product; or has an allergic constitution (allergic to multiple drugs and foods);
Systolic blood pressure (SBP) < 160 mmHg, diastolic blood pressure (DBP) < 100 mmHg;
Fasting TG ≤ 5.6 mmol/L, fasting TC ≤ 7.5 mmol/L, fasting LDL-C ≤ 5 mmol/L, and abnormal fasting HDL-C;
Alanine aminotransferase (ALT) < 2 × ULN, aspartate aminotransferase (AST) < 2 × ULN, gamma-glutamyl transferase (GGT) < 2.5 × ULN, and total bilirubin (TBIL) < 1.5 × ULN. Participants with values outside the normal range may be included if the abnormality is deemed benign by the investigator (e.g., Gilbert's syndrome);
Parallel
SYH2082 Injection
DrugA subcutaneous injection in the abdomen of the corresponding dose of SYH2082 Injection according to the assigned dose cohort.
Placebo
DrugA subcutaneous injection in the abdomen of the corresponding dose of Placebo according to the assigned dose cohort.
Number of Adverse Events as a measure of safety and tolerability of SYH2082
Maximum plasma concentration (Cmax)
Area under the concentration-time curve from time 0 to the last measurable time point (AUClast)
Area under the concentration time curve from time 0 to infinity (AUCinf)
Time to maximum concentration (Tmax)
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