A Single Ascending Dose Study of SYH2082 Injection in Healthy Participants

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Overweight or Obesity

In brief

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

Key facts

Study ID

NCT07532655

Run by

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

People needed

44

Starts

2026-04-14

Expected to finish

2027-02-09

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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);
• 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.

You may not qualify if…

• 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, and ECG that are judged by the investigator to be clinically significant within the screening period. Specifically, the following conditions are not excluded:
• 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);
• History or laboratory evidence of diabetes mellitus (type 2, type 1, or other forms of diabetes), including fasting glucose of ≥126 mg/dL (7.0 mmol/L) and/or HbA1c ≥ 6.5% within the screening period;
• With any previous episode of hypoglycemia or with screening fasting glucose < 3.9mmol/L (even on a single sample);
• With obesity due to identifiable endocrinologic, genetic or syndromic causes;
• Meets any of the following criteria within the screening period:
• Calcitonin ≥25 ng/L;
• Estimated glomerular filtration rate (eGFR) <80 mL/min/1.73m2
• Thyroid-stimulating hormone (TSH) outside the normal reference range;
• Fasting serum amylase and/or lipase >1.5× ULN.
• At screening, has a prolonged QT/QTc interval (QTcF >450 ms for males and QTcF>470 ms for females), or a history of risk factors for Torsades de Pointes (e.g., cardiac failure/cardiomyopathy or a family history of long QT syndrome), or is currently taking concomitant medications that prolong the QT/QTc interval;
• Positive for any of the following: Hepatitis B surface antigen, Hepatitis C virus antibody, human immunodeficiency virus antibody, or syphilis serology;
• Significant history or clinical manifestation of any metabolic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, immune or psychiatric disorder as determined by the Investigator or medical designees;
• History of severe trauma or major surgery within 3 months prior to screening, or plans to undergo surgery or any procedures requiring general anesthesia or sedation during the study period;
• History of thyroid nodules diagnosed as C-TIRADS category 3 or higher;
• Personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia syndrome type 2, or a personal history of pancreatitis or gallbladder/gallstone disease;
• History of malignancy, except for non-melanoma skin cancer excised more than 1 year prior to Screening and cervical intraepithelial neoplasia that has been successfully cured more than 2 years prior to Screening;
• History of major depressive disorder, including any medication or psychological therapy, in the last 2 years, or any clinically significant mental health condition;
• Lifetime history of any suicide attempts or suicide behavior according to the C-SSRS, or any suicidal ideation in the last two years according to the C-SSRS;
• Non-suicidal self-injury more than 5 years ago is permissible, if it is clear there was no suicidal intent. Participants should be excluded if any doubt;
• History of gastric emptying abnormalities (e.g., gastric outlet obstruction) or severe chronic gastrointestinal diseases (e.g., inflammatory bowel disease, active ulcer);
• History of gastrointestinal surgery that could lead to malabsorption, or long-term use of drugs that directly affect gastrointestinal motility. For example: has undergone bariatric surgery or procedures (e.g., gastric banding) within 3 months prior to screening;

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