Type 2 Diabetes Mellitus
Conditions
Interventions
Test group:Injection E4F4
Control Group:placebo
Sponsors
Phase I Clinical Trial Laboratory of Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.The subjects voluntarily participated and signed the informed consent form, and agreed to comply with all test requirements; 2.Female subjects took effective contraceptive measures within 1 month before screening, and the blood pregnancy test result was negative; The subjects or their spouses use appropriate and effective contraceptive measures, such as abstinence, intrauterine device and double barrier method(such as condom and contraceptive diaphragm, excluding the use of contraceptives), from the signing of informed consent to 12 months after receiving the trial drug; 3.Aged 18 to 45 years (subject to the day of signing the informed consent form), both men and women, the ratio of men to women in each group is close to 1:1; 4.The body mass index (BMI) is between 19.0~26.0kg/m2 (including 19.0 and 26.0kg/m2), and the weight of male is >=50kg, and the weight of female is >=45kg; 5.Physical examination, vital signs, laboratory examinations and other auxiliary examinations are normal or abnormal but no clinical significant.
Exclusion criteria
Exclusion criteria: 1.Have undergone major surgery within 6 months before the administration, or plan to undergo surgery within one month after the end of the trial; 2.Blood donation or massive blood loss > 450ml within 3 months before screening; 3.Known to be allergic to GLP-1R drugs or to any of the excipients in this product or allergic physique (>=2 allergic substances); 4.Smoking more than 5 cigarettes per day in the 3 months before signing the informed consent, or not using any tobacco products during the trial period; 5.Within 3 months before signing the informed consent, the weekly alcohol consumption is more than 14 units (1 unit of alcohol ˜ 360ml beer or 45ml of spirits with 40% alcohol content or 150ml wine), the alcohol breath test is positive, or the alcohol can not be banned during the test; 6.COVID-19 vaccine was injected within 1 months before administration; 7.Urine drug screening test (morphine, methamphetamine, ketamine, dimethylbisoxyamphetamine, tetrahydrocannabinol acid) is positive or has a history of drug abuse or drug use in the past five years; 8.Participated in other drug clinical trials within 3 months before screening (the last visit time of the last trial is calculated as the start time); 9.Previous serious diseases with abnormal clinical manifestations that need to be excluded, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases; 10.Within 4 weeks prior to the signing of the informed consent, any infectious diseases, such as bacterial, viral, fungal, parasitic infections or other infections, are required to be treated or hospitalized; 11.Subjects with medullary thyroid cancer or multiple endocrine adenoma syndrome type 2 disease, or a family history of such diseases. 12.History of acute and chronic pancreatitis; 13.History of hypertension; 14.Definitely diagnosed type 1 diabetes or type 2 diabetes; 15.Hypoglycemia occurred 12 months before screening; 16.Take any prescription drugs, over-the-counter drugs, any vitamin products or herbal medicines in the 14 days before screening; 17.Plan to participate in strenuous exercise during the test, including contact sports or collision sports; 18.Plan to donate sperm or eggs within 12 months after the trial drug is administered; 19.Employees or related personnel of investigators, clinical trial institutions, sponsors, and contract research organizations; 20.The screening examination does not meet the health standards, mainly including:Vital signs are abnormal and clinically significantLaboratory test results are abnormal and clinically significant; Physical examination results are abnormal and clinically significant;The ECG results are abnormal and clinically significant, or male QTc>470ms, female QTc>480ms; The QTc calculation method uses the Bazett method QTcB = QT/(RR^0.5), RR is the standardized heart rate value, which is obtained by dividing 60 by the heart rate;Chest X-ray examination results are abnormal and clinically significant, except for increased lung texture without clinical respiratory symptoms or signs; 21.Hepatitis B surface antigen (HBsAg), hepatitis C antibody (IgG), hepatitis C virus core antigen, human immunodeficiency virus (HIV) antibody, Treponema pallidum specific antibody (TP-Ab) tests positive for any one of them; 22.Other situations in which the investigator judges that it is not suitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety;tolerability; | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics (PK);pharmacodynamics (PD);immunogenicity; | — |
Countries
China
Contacts
Public ContactChen Guiling
Shulan (Hangzhou) Hospital
Outcome results
None listed