Primary Objectives:
•To evaluate the safety and tolerability of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059）in Chinese subjects with T2DM.
Secondary Objectives:
* To characterize the pharmacokinetic (PK) profile of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059） in Chinese subjects with T2DM; * To characterize the pharmacodynamic (PD) profile of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059） in Chinese subjects with T2DM; * To evaluate the immunogenicity of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059） in Chinese subjects with T2DM;
Participants :
Diagnosed with T2DM for at least 3 months but less than 5 years, according to the Chinese Diabetes Society's diagnostic criteria
Chinese male or female， 18≤age≤-65 years .
Diagnosed with T2DM for at least 3 months but less than 5 years, according to the Chinese Diabetes Society's "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2024 Edition)" diagnostic criteria.
Patients who have failed treatment with diet and exercise alone, or metformin monotherapy, or a stable regimen for 12 weeks of metformin (dose ≥1500 mg/day or maximum tolerated dose ≥1000 mg/day) combined with one of the following oral antidiabetic drugs (or their fixed-dose combinations): sulfonylureas, glinides, alpha-glucosidase inhibitors, SGLT2 inhibitors, or thiazolidinediones (at ≥1/2 the maximum approved dose, or the recommended minimum maintenance dose for SGLT2 inhibitors e.g., empagliflozin 10mg, canagliflozin 100mg). Fasting Plasma Glucose (FPG) must be <13.0 mmol/L, and 7.5%≤HbA1c ≤ 10.0%.
18.5 kg/m²≤Body Mass Index (BMI) ≤40.0 kg/m² at screening and enrollment
Diagnosis of type 1 diabetes, diabetes due to pancreatic injury, or specific types of diabetes due to other diseases (e.g., acromegaly or Cushing's syndrome).
History of acute diabetic complications, such as ketoacidosis or hyperosmolar coma, within 6 months before screening.
Presence of severe chronic diabetic complications (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months before screening, deemed by the investigator as unsuitable for participation.
Allergic constitution (allergy to ≥2 types of drugs or foods) or keloid tendency, or clear history of drug allergy, or investigator suspects potential allergy to the investigational product or its components or similar drugs.
Single group
Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059））
Druguse one dose per person
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Adverse events (AEs) / Serious adverse events (SAEs) will be collected via: Laboratory tests (including complete blood count, blood biochemistry, glucagon, lipase, amylase, urinalysis, coagulation function, high-sensitivity C-reactive protein, inflammatory factors); Vital signs (blood pressure, pulse rate, body temperature, respiration); Physical examinations (including skin, mucous membranes, lymph nodes, head and neck, chest, abdomen, spine and extremities, and musculoskeletal tissues); 12-lead electrocardiogram (12-lead ECG, including PR interval, QRS duration, QTcF interval); Abnormalities observed by the investigator; Subject-reported complaints.
Pharmacokinetic
Cmax
Pharmacokinetic
Tmax
Pharmacokinetic
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration（AUC0-last）
Pharmacokinetic
Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-inf)
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The First Affiliated Hospital of Henan University of Science and Technology
Lead sponsor
PegBio Co., Ltd.
Collaborator
