A Clinical Study Comparing the Pharmacokinetics and Pharmacodynamic Characteristics of Insulin Degludec Injection (RD15003) and Insulin Degludec Injection (Tresiba®) in Healthy Subjects

Exclusion Criteria

• •1. Have a history of hypoglycemia within 3 months before screening;
• •2. Those who have taken any prescription drugs, Chinese herbal medicines, over-the-counter drugs (except for subjects with occasional and restricted use of paracetamol), and health care products (except routine supplementary vitamins and calcium) within 4 weeks before administration;
• •3. During screening, the test results of human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody or Treponema pallidum antibody were positive;
• •4. Have a history of malignant tumors before screening;
• •5. Participated in any drug or device clinical research within 3 months before screening (the definition of participation: refers to random or receiving experimental drugs or devices);
• •6. Blood donation \> or = 400 mL within 3 months before administration, or blood loss \> or = 400 mL due to any reason;
• •7. People who are known to be allergic to the test drug or its excipients;
• •8. People who drink regularly within 3 months before administration, that is, drink more than 21 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% alcoholic spirits or 150 mL of wine), or those who have a positive alcohol breath test ;
• •9. Those who have a positive urine drug screening;
• •10. Positive anti-insulin antibody during the screening period;
• •11. Female subjects who are breastfeeding, or women who have a positive blood pregnancy test during the screening period;
• •12. Those who smoked more than 10 cigarettes per day within 3 months before the administration, or failed to comply with the ban on smoking during the trial period;
• •13. There are any factors considered by the researcher to be unsuitable for participating in the research;
• •14. If during the period of new coronary pneumonia, the investigator decided to conduct relevant tests for the new coronavirus according to the requirements of the Sichuan Provincial Health Commission and West China Hospital of Sichuan University at the time of the trial, and the abnormal results have clinical significance.