Overweight or Obesity
Conditions
Brief summary
To evaluate the safety and tolerability of single dose of SYH2082 Injection in healthy participants.
Interventions
A subcutaneous injection in the abdomen of the corresponding dose of SYH2082 Injection according to the assigned dose cohort.
DRUGPlacebo
A subcutaneous injection in the abdomen of the corresponding dose of Placebo according to the assigned dose cohort.
Sponsors
CSPC Ouyi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Interventional
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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;
Exclusion criteria
* 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; * 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; * Subjects with severe trauma or major surgery within 6 months prior to screening, or planned to undergo surgery during the trial; * Patients with thyroid nodules diagnosed as C-TIRADS category 3 or above in the past or during the screening period; * 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); * 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. * Those who have symptoms such as dermatitis or skin abnormalities at and around the administration site; * 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; * 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);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events as accessed by CTCAE v6.0 | Screening period up to day 57 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) | Pre-dose at day 1 to day 57 | — |
| Area under the concentration-time curve from time 0 to the last measurable time point (AUClast) | Pre-dose at day 1 to day 57 | — |
| Area under the concentration time curve from time 0 to infinity (AUCinf) | Pre-dose at day 1 to day 57 | — |
| Percent of AUC extrapolated to infinity (AUC_Extrap) | Pre-dose at day 1 to day 57 | — |
| Time to maximum concentration (Tmax) | Pre-dose at day 1 to day 57 | — |
| Elimination half-life (t1/2) | Pre-dose at day 1 to day 57 | — |
| Apparent volume of distribution (Vz/F) | Pre-dose at day 1 to day 57 | — |
| Apparent clearance (CL/F) | Pre-dose at day 1 to day 57 | — |
| Anti-SYH2082 antibodies (ADA) | Pre-dose at day 1 to day 57 | — |
| Mean change in plasma glucose from baseline | Baseline up to Day 57 | — |
| Mean change in insulin from baseline | Baseline up to Day 57 | — |
| Mean change in C-peptide from baseline | Baseline up to Day 57 | — |
| Mean change in glucagon from baseline | Baseline up to Day 57 | — |
| Mean change in HbA1c from baseline | Baseline up to Day 57 | — |
| Change in body weight from baseline | Baseline up to Day 57 | — |
| Change in waist circumference from baseline | Baseline up to Day 57 | — |
| Mean change in Total Cholesterol(TC) from baseline | Baseline up to Day 57 | — |
| Mean change in Triglycerides(TG) from baseline | Baseline up to Day 57 | — |
| Mean change in Low-Density Lipoprotein Cholesterol(LDLC) from baseline | Baseline up to Day 57 | — |
| Mean change in High-Density Lipoprotein Cholesterol(HDLC) from baseline | Baseline up to Day 57 | — |
| Change in blood pressure from baseline | Baseline up to Day 57 | — |
| Change in Visceral Fat from baseline via Bioelectrical Impedance Analysis (BIA) | Baseline up to Day 57 | — |
| Change in Body Fat from baseline via Bioelectrical Impedance Analysis (BIA) | Baseline up to Day 57 | — |
| Change in Skeletal Muscle from baseline via Bioelectrical Impedance Analysis (BIA) | Baseline up to Day 57 | — |
| Corrected QT(QTc) interval | Pre-dose at day 1 to day 8 | Baseline- and placebo-corrected QTcF (ΔΔQTcF) |
Countries
China
Outcome results
None listed