Type 2 Diabetes
Conditions
Interventions
1:Exendin-4 Fc Fusion protein injection 0.3mg
2:Exendin-4 Fc Fusion protein injection 0.7mg
3:Exendin-4 Fc Fusion protein injection 1.5mg
4:Exendin-4 Fc Fusion protein injection 3mg
5:Exendin-4 Fc Fusion protein injection 6mg
Sponsors
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
All
Age
15 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1) Males or females aged between 18 and 45 without gender ratio limitation; 2) Healthy subjects (refers to normal healthy adults who are not clinically significant and have no psychiatric diseases by medical history inquiry, careful physicalvital signs examination, laboratory tests and auxiliary examinations, or who are judged as healthy by investigators); 3) Male body weight= 50 kg, female body weight= 45 kg and body mass index (BMI)is 18-26 kg/m2; 4) Voluntary signature of Informed Consent Form; 5) In order to avoid pregnancy of themselves or their partners subjects should take appropriate contraceptive measures (not including relative drugs) during the trial and 6 months after withdraw; termination of pregnancy is recommended if the partner accidentally pregnancies during the trial and 6 months after withdraw; blood and urine HCG of female subjects are negative.
Exclusion criteria
Exclusion criteria: 1) Smokers who quit smoking for less than 3 months or who cannot quit smoking during the trial; 2) Use any prescription drug within 4 weeks before administration; use any over-the-counter drug (vitamins, Chinese herbal supplements, health foods) within 2 weeks before administration, use any immunosuppressive agent within 1 year before administration, use any steroid or are receiving treatment that directly reduces gastrointestinal motility; 3) Participate in any clinical trial within 3 months; 4) Blood donation or blood loss =400 mL within 3 months; 5) Suffered from serious diseases within 2 weeks and was not suitable to participate the trial according to the judgement of the investigators; 6) Significant clinical allergic history of drugs or atopic allergic history or has known allergy to experimental drugs or similar drugs; 7) Investigators believe that there are clinically significant digestive tract diseases such as liver and gallbladder diseases, gastrointestinal diseases, gastrointestinal surgery (except appendectomy),chronic pancreatitis or idiopathic acute pancreatitis; 8) a disease or family history of Medullary thyroid cancer (MTC) or genetic diseases which can induce medullary thyroid cancer; 9) Suffering from serious, progressive and uncontrolled diseases of liver, kidney, blood, gastrointestinal tract, endocrine, heart, lung, nerve and brain etc; 10) With a history of malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK; | — |
Countries
China
Contacts
Public ContactJuan Li
Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed