A Study of SYH2082 Injection in Healthy Participants

Korábbi kezelés

• Subjects with severe trauma or major surgery within 6 months prior to screening, or planned to undergo surgery during the trial;
• Previous gastrointestinal surgery leading to malabsorption, or long-term use of drugs that have a direct effect on gastrointestinal motility. e.g., bariatric surgery or procedures (e.g., gastric banding), or use of GLP-1 or GIP receptor agonists or drugs or products that, in the opinion of the investigator, may cause weight change and affect weight assessment within 3 months prior to screening.
• Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 2 weeks before screening, or less than 5 half-lives since the last dose of the above-mentioned drugs;

Más betegség

• Those who are positive for any of hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and Treponema pallidum antibody;
• History or presence of major cardiovascular, respiratory, digestive, urinary, hematological, endocrine, immune or nervous system diseases;
• Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2, or history of pancreatitis or acute or chronic gallbladder disease;
• Those with a history of malignant tumors, mental illness, depression, anxiety, or epilepsy;
• History of clinical gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as inflammatory bowel disease, active ulcer);

Laborértékek

• 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);
• Abnormal results in vital signs, physical examination, laboratory tests, chest X-ray, ultrasound and ECG that are judged by the investigator to be clinically significant within the screening period. Specifically, the following conditions are not excluded: 1)Systolic blood pressure (SBP) \< 160 mmHg, diastolic blood pressure (DBP) \< 100 mmHg;2)Fasting TG ≤ 3.42 mmol/L, fasting TC ≤ 7.75 mmol/L(with abnormal HDL-C regardless of LDL-C status); 3)Alanine aminotransferase (ALT) \< 2 × ULN, aspartate aminotransferase (AST) \< 2 × ULN, gamma-glutamyl transferase (GGT) \< 2.5 × ULN, and total bilirubin (TBIL) \< 1.5 × ULN.4) Blood uric acid \<480 μmol/L and never accompanied by physiological abnormalities (gout, etc.); 5) Ultrasound shows fatty liver and excludes causes
• Meet any of the following at screening: (1) HbA1c \> upper limit of normal, or fasting blood glucose ≤ 3.9 mmol/L or ≥ 6.1 mmol/L; (2) Calcitonin ≥ 50 ng/L; (3) eGFR \< 90 mL/min/1.73m 2; (4) TSH exceeds the normal reference range; 4) Patients with prolonged QT/QTc interval at screening (QTcF \> 450 ms), or have a history of risk factors for torsades de pointes (such as family history of heart failure/cardiomyopathy or long QT syndrome), or are taking concomitant medications that prolong the QT/QTc interval;
• Use of drugs that may affect glucose metabolism (e.g., systemic steroids, non-selective beta-blockers, monoamine oxidase inhibitors) within 1 month before screening, or less than 5 half-lives since the last dose of the above-mentioned drugs (whichever is longer);

Egyéb

• Patients with thyroid nodules diagnosed as C-TIRADS category 3 or above in the past or during the screening period;
• Those who have symptoms such as dermatitis or skin abnormalities at and around the administration site;

• Fully understands the content, procedures, and possible adverse reactions of the study, and voluntarily signs the ICF before the study;
• At screening, age 18-55 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 19.0 and 35.0 kg/m2 (inclusive);
• Body weight change ≤5% within 3 months prior to screening (including the screening period);
• From the time of signing the ICF until 6 months after the last dose, the participant (including their partner) has no plans for childbirth and agrees to use highly effective contraceptive measures;