Male healthy volunteers
Conditions
Interventions
Arm A:None
Arm B:None
Sponsors
Peking University Peoples Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Volunteerly participate, informed consent form be signed; 2. Between 18 and45 years old, adult male healthy volunteers; 3. Screening examination 30 days prior to administration, body mass index (BMI) in between 19~24, body weight is in the range of 45~75kg; 4. subjects should use effective contraception during study until 6 months after the end of study; 5. The health result should be good by investigators assessment based on physical examination, medical history, vital signs, electrocardiogram (ECG) and so on; 6. The subjects can make good communication with investigators and can be completed the study in accordance with the requirements.
Exclusion criteria
Exclusion criteria: 1. Known allergic to any components of investigative product or any drug, food or pollen; abnormality of immunoglobulin E (IgE) test; 2. Currently have any symptoms, signs and there may be acute or sub-acute infection based on laboratory abnormalities suggests (such as fever, cough, urgency, urine pain, abdominal pain, diarrhea, skin wound infection, etc.); 3. Known narcotic drugs history or drug abuse by inquired; 4. Known disease history of disease of central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, metabolic system or other significant diseases. Or systolic blood pressure more than 140 mmHg, or diastolic blood pressure more than 90 mmHg, and have clinical significance judging by the researchers during screening. Know postural hypotension; 5. Known cancer family history; 6. Previously participation of any other clinical trials in the recent 3 months, or use of any drugs known to damage major organs within 3 months; 7. Blood donation in 3 months. 8. Underwent surgery in 3 months before enrolled. 9. Previously use of any dugs, both prescrided or OTC in 14 days; 10. ALT or AST>1.5 N (N= upper limit of normal value) and Cr>N; 11. Blood testing: WBC9.5×10^9/L; ANC<1.5×10^9/L; <100×10^9/L; HGB<10^4 g/L; 12. Positive result of liver surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV and syphilis helicoid antibody (TP Ab); 13. Positive result of anti-drug antibody (ADA); 14. Positive result of tumor markers (CEA, AFP, PSA, CA - 125); 15. Coagulant function abnormality, and have clinical significance judging by the researchers; 16. A history of peptic ulcer, cerebrovascular accident, vascular lesions, currently have open wounds of skin mucous membrane, or other may be risk of bleeding or clotting volunteers judging by researchers; 17. Know mental illness; 18. Cigarettes intake more than 5 cigarettes per day or the same amount of tobacco; 19. Alcohol abuse (more than 28 units/week(1 unit=285 ml beer or 25 ml spirits or 1 glass of wine); or positive results of alcohol breath test obtained in 24 hour; 20. Any clinical laboratory abnormality during screening; 21. Lack of ability of communication, understanding of the study and cooperation; lack of compliance or ability to follow protocol procedures; 22. Any other exclusion decision from investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;AUC0-8;Tmax;Vd;t1/2;CL;Ke; | — |
Countries
China
Contacts
Public ContactYi Fang
Peking University Peoples Hospital
Outcome results
None listed