Healthy male subjects
Conditions
Interventions
Recombinant humanized monoclonal antibody against VEGF (JY028) injection:A single dose of 3mg/kg
Bevacizumab Injection (Bevacizumab Injection
Name: Avastin:A single dose of 3mg/kg
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
Male
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. The subjects fully understand the purpose, nature, method and possible adverse reactions of the trial, voluntarily act as the subjects, and sign the informed consent form before the start of any research procedure, and ensure that I will participate in the study in any procedure; 2. Subjects who can communicate well with researchers and understand and comply with the requirements of this study; 3. The subjects had no history of chronic or serious diseases such as cardiovascular, liver, kidney, respiration, blood and lymph, endocrine, immune, mental, nervous, gastrointestinal system and other serious diseases, and well overall health condition; 4. During the screening period and the next 6 months, the subjects had no family planning, and they voluntarily took effective contraceptive measures and no sperm donation plan, and they should voluntarily use non drug contraceptive measures during the trial period; 5. Male subjects aged 18-50 years (including 18 and 50 years old); 6. Male body weight >=50.0kg, body mass index (BMI) in the range of 19.0 ~ 26.0kg/m2 (including the critical value); 7. Vital signs examination, physical examination, clinical laboratory examination (blood routine, urine routine, blood biochemistry, blood transfusion, coagulation function, drug screening, etc.), 12 lead ECG, chest X-ray examination and abdominal B-ultrasound examination, the results show that there are no abnormal or abnormal objects without clinical significance.
Exclusion criteria
Exclusion criteria: 1. Health status: clinical history of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymph system, immune system, mental disorders, metabolic abnormalities and skeletons; 2. Subjects who have allergic history to bevacizumab or any component of the drug; those who have allergic history and are not suitable for the group according to the researcher's judgment; 3. Patients who have received surgery within 3 months before screening, or who plan to have surgery during the study period, and those who have received surgery that will affect the absorption, distribution, metabolism and excretion of drugs; 4. Patients who can not tolerate venipuncture or have a history of needle syncope and blood sickness; 5. Screening the subjects who had a history of drug abuse in the first 6 months; 6. Screening the subjects who used drugs in the past three months; 7. Those who received blood transfusion or used blood products within 3 months before screening, including blood component or massive blood loss (>=200ml); 8. The subjects had a family planning or sperm donation plan in the screening period and the next 6 months; 9. Those who have used any prescription drugs, over-the-counter drugs, Chinese herbal medicines and dietary supplements / health products (including vitamins, etc.) within 2 weeks before screening; 10. Those who have received vaccination within 4 weeks before screening, or who plan to be vaccinated during the study period; 11. The subjects who smoked more than 5 cigarettes a day within 3 months before screening, or who could not stop using any tobacco products during the test period; 12. Those who drank more than 14 units a week in the first three months (1 unit alcohol ˜ 360 ml beer or 45 ml strong liquor with 40% alcohol content or 150 ml wine), or those who could not be banned during the test period; 13. The subjects who drank excessive amount of tea, coffee and / or caffeinated drinks every day in the first three months (more than 8 cups per day, 1 cup = 250 ml per day); 14. Excessive consumption of pitaya, mango, pomegranate, kiwi fruit, grapefruit, lime, carambola or the food or beverage prepared by them within 7 days before screening; 15. They have special requirements on diet and can not accept the object of unified diet; 16. The subjects who participated in the drug clinical trial and used the trial drug within 3 months before screening; 17. For subjects with abnormal vital signs, refer to the normal range (including critical value): sitting systolic blood pressure 90 ~ 139mmhg, diastolic blood pressure 60 ~ 89mmhg, pulse 60-100 times / min, body temperature (ear temperature) 35.4 ~ 37.7 degree C, breath 16 ~ 20 times / min, the specific situation should be comprehensively determined by the researcher; 18. Laboratory examination and auxiliary examination of any items abnormal and judged by the researcher as having clinical significance; 19. Hepatitis B virus, hepatitis C virus antibody, anti human immunodeficiency virus antibody or anti Treponema pallidum specific antibody test has one or more objects with clinical significance; 20. Those whose results of alcohol breath test are greater than 0.0mg/100ml or those who are positive for drug screening (morphine, methamphetamine, ketamine, ecstasy and cannabis, respectively); 21. Patients with acute disease from screening to - 1 day admission; 22. Subjects who took any prescription drugs, over-the-counter drugs, Chinese herbal m
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pharmacokinetic evaluation index AUC0- T; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation index;Other pharmacokinetic parameters: Cmax, AUC0-infinity, Tmax, T1/2, Z, Vd, CL, %AUCext;Immunogenic indicators; | — |
Countries
China
Contacts
Public ContactHongzhou Lu
Shanghai Public Health Clinical Center
Outcome results
None listed