A Single Ascending Dose Study of SYH2082 Injection in Healthy Participants

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

About this trial

To evaluate the safety and tolerability of single dose of SYH2082 Injection in healthy participants.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • SYH2082 Injection
  • Placebo

Treatment groups

44 Participants
are divided into 2 treatment groups

Locations

This trial has no locations