| Eligibility |
Inclusion Criteria:
- 1. Male subjects between 18 and 45 years of age, inclusive;
- 2. The subject is in good health as determined by medical history, physical
examination and clinical laboratory parameters, such as vital signs, 12-lead ECG,
imaging examinations (such as thyroid color Doppler ultrasound, abdominal color
Doppler ultrasound, chest X-ray);
- 3. Weight = 50kg, body mass index (BMI) between 19-26 kg / m2 (inclusive) [BMI =
weight (kg) / height 2 (m2)];
- 4. The subject has a blood glucose between 3.9-6.1 mmol / L (exclusive) and the HbA1c
< 6.5%;
- 5. From the date of signing an informed consent to at least 3 months after the
administration, the subject must use reliable contraceptive methods to prevent
pregnancy;
- 6. The subjects fully understand the content of the trial and the possible adverse
reactions, have the ability to communicate with the researchers normally, willing and
able to comply with all requirements defined in the protocol;
- 7. Voluntarily to participate in the study and sign the informed consent form.
Exclusion Criteria:
- 1. Subjects who have a history of certain allergic conditions (such as asthma,
urticaria), or have a history of allergy to two or more drugs or food, or may be
allergic to the test drug and the related compounds;
- 2. Have a history of serious diseases, such as neurological, hepatic, renal,
cardiovascular, haematological, pulmonary diseases, or other significant diseases
capable of significantly altering the absorption, metabolism, or elimination of the
study drug, of constituting a risk when taking the study drug; or of interfering with
the interpretation of data;
- 3. Have undergone major surgery within 3 months before screening or have severe
infection within 4 weeks before screening;
- 4. With thyroid dysfunction requiring drug treatment, or not reaching clinical
stability after treatment, or with other endocrine diseases that may affect blood
glucose metabolism;
- 5. Have a history of or current pancreatitis (history of chronic or acute
pancreatitis);
- 6. Have a history of or current cholecystitis;
- 7. With clinically significant abnormal gastric emptying (such as gastric outlet
obstruction) and severe chronic gastrointestinal diseases (such as active ulcer within
6 months);
- 8. Have a history (or family history) of medullary thyroid cancer (MTC), type 2
multiple endocrine neoplasia syndrome or other hereditary diseases that are thought to
induce MTC;
- 9. Have a history of malignant tumour, mental illness, depression, anxiety and
epilepsy;
- 10. Have a history of drug dependence in the past one year or have a positive urine
drug screen before administration;
- 11. Vaccinated within 28 days before screening or planned to be vaccinated within 1
week after receiving the study drug;
- 12. Have a positive test result of hepatitis B surface antigen, hepatitis C antibody,
anti-human immunodeficiency virus antibody or anti-Treponema pallidum specific
antibody;
- 13. Blood loss greater than 400 ml due to blood donation or other reasons within 3
months before screening;
- 14. Have used Glucagon-like peptide-1 (GLP-1) analogues, GLP-1 receptor agonists or
any other incretin analogues three months before the planned study drug , or other
drugs that are thought to affect the trial in the opinion of the researchers;
- 15. Within 3 months before administration, subjects used drugs that may cause changes
in blood glucose level;
- 16. Have used any prescription drug, Chinese herbal medicine or over-the-counter drug
within 15 days before screening that are capable of affecting the PK, PD and safety
outcomes;
- 17. Average alcohol intake is more than 21 units of alcohol (male) per week (1 unit ˜
360mL beer, or 45mL spirits with 40% alcohol content, or 150mL wine) within the 3
months prior to screening, or a positive ethanol breath test at screening;
- 18. Regularly consumption of caffeine is more than 600 mg per day within the 3 months
prior to screening (one cup of coffee contains about 100 mg of caffeine, one cup of
tea contains about 30 mg of caffeine, and one can of coke contains about 20 mg of
caffeine), or those who used caffeinated products within 48 hours before
administration;
- 19. Smoking more than 5 cigarettes per day within 3 months prior to screening;
- 20. According to the judgment of the researcher, the subjects have special dietary
requirements;
- 21. With dermatitis or abnormal skin conditions at or around the site of
administration;
- 22. Have participated in another clinical trial involving an investigational product
within 3 months prior to the planned administration of the study drug; or the last
dose of the previous investigational product has been given in less than 3 months
before the screening; or those who would try to participate in other clinical trials
during the study period;
- 23. Not suitable for this study in the researcher's opinion, such as subjects with
poor compliance (long-term business trip, planned relocation, etc.).
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