Type 2 diabetes
Conditions
Interventions
2mg/40µCi group:Subcutaneous injection of approximately 2 mg/40 µCi, administered only once.
Sponsors
Affiliated Hospital of Jiangnan University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male, aged 18–45 years at the time of informed consent (ICF) signature. 2. Body mass index within the range of 19.0 to 35.0 kg/m^2, and a minimum weight of 60 kg at screening. 3. The subject is willing to voluntarily take appropriate and effective contraceptive measures from the screening period to 12 months after administration of the investigational drug, and has no plans for fertility or sperm donation within 12 months after administration of the investigational drug. 4. Able to communicate effectively with investigators, fully understands the study, voluntarily participates, and understands and complies with all requirements of this study, and signs a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. History of clinically significant injection-site reactions, or known hypersensitivity to the investigational medicinal product or other drugs of the same class, special dietary requirements, or atopic diathesis. 2. Participant with a history of any clinically significant disease or condition that, in the investigator's judgment, may affect the trial outcomes, including but not limited to respiratory, circulatory, digestive, urinary, hematological, endocrine, immune, nervous, or psychiatric systems, or those with existing diseases in these systems that may significantly alter drug absorption, metabolism, or excretion, posing risks associated with the use of the investigational product, or those with a history of malignancy, or any condition that may interfere with data interpretation and deemed unsuitable for participation by the investigator. 3. Participant with a history of significant gastric emptying abnormalities or any factor known to impair gastric emptying, or current symptomatic gastrointestinal disease. 4. Pancreatitis with a history of acute pancreatitis within 6 months prior to screening, or history of chronic pancreatitis or pancreatic surgery. 5. History of severe hypoglycaemic episodes. 6. Use of any prescription medication, over-the-counter product, herbal remedy, or dietary supplement within 14 days prior to screening. 7. Prior exposure to GLP-1 receptor agonists, GLP-1R/GCGR , GLP-1R/GIP co-agonists, or GLP-1R/GIPR/GCGR tri-agonists within 3 months, or any other large-molecule agent within 6 months prior to screening. 8. Receipt of any vaccine within 1 month prior to screening, or planned vaccination during the study. 9. Clinically significant abnormal findings on physical examination, laboratory tests, chest X-ray (PA view), ECG, or abdominal ultrasound, as assessed by the investigator. 10. Vital-sign values outside the acceptable range that remain abnormal on repeated measurement. 11. Positive test for hepatitis B surface antigen, hepatitis C antibody, Treponema pallidum antibody, or HIV antibody at screening and assessed as clinically significant by the investigator. 12. Prior surgery judged by the investigator to interfere with drug absorption, distribution, metabolism, or excretion, or major surgery within 6 months prior to screening with incomplete wound healing. "Major surgery" includes, without limitation, any procedure associated with significant bleeding risk, prolonged general anaesthesia, open biopsy, or major traumatic injury, or surgery planned during the study. 13. Blood loss or donation > 400 mL, or receipt of whole blood or blood components, within 3 months before dosing. 14. Participation in another clinical trial within 3 months prior to screening or during screening, with use of an investigational medicinal product or device; intention to enter another trial during this study; or sending a surrogate to sign consent. 15. Occupational long-term exposure to ionising radiation, or significant radiation exposure within 1 year before screening, or participation in a radionuclide-labelled drug study within 1 year. 16. History of drug abuse or positive urine drug screen. 17. Use of > 5 cigarettes/day or equivalent tobacco within 3 months before dosing, inability to abstain during the study, or positive urinary cotinine at check-in. 18. Alcohol abuse or regular alcohol consumption within 6 months prior to screening,> 14 units/week, or breath-alcohol > 0 mg/100 mL at baseline, or inability to abstain from
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total radioactivity ratio of [14C]UBT251 in whole blood/plasma;Total radioactive recovery and cumulative total radioactive recovery at each collection time in excreta [(exhaled breath (if applicable), urine, and feces)];The percentage of the parent drug and its metabolites in plasma relative to the total radioactive exposure in plasma (%AUC); the percentage of the parent drug and its metabolites in urine and feces relative to the administered dose (% dose); identification of major metabolites in plasma, urine, and feces.;PK parameters of total radioactivity in whole blood (if applicable) and plasma: time to peak (Tmax), peak concentration (Cmax), area under the blood concentration-time curve, terminal elimination half-life (t1/2z), apparent volume of distribution (Vz/F), clearance, mean residence time, etc.; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters of plasma UBT251 and its metabolites (if applicable): time to peak concentration (Tmax), peak concentration (Cmax), area under the plasma concentration-time curve, terminal elimination half-life (t1/2z), apparent volume of distribution, plasma clearance, mean residence time, etc.;Laboratory test indicators; | — |
Countries
China
Contacts
Public ContactZhao Yiqing, Bao Jiachun
Affiliated Hospital of Jiangnan University
Outcome results
None listed