Breast cancer
Conditions
Interventions
experimental group:Recombinant Human HER2 Monoclonal Anitbody for Injection
control group:Heceptin
Sponsors
Peking University Peoples Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Volunteerly participate, informed consent form be signed; 2. Aged 18 to 45 years old men and women, with batch participants' age are no more than 10 years apart; 3. Screening examination 28 days prior to administration, body mass index (BMI) in between 19~24, body weight is in the range of 45~75kg; 4. The subjects agreed and took reliable contraceptive measures to ensure that there were no birth plans within 3 months of the start of the study; 5. Subjects are able to make good communication with researchers and can be completed in accordance with the provisions of the research study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; or women in childbearing age whose pregnancy test are positive; or who having a fertility, but failed or unwilling to take effective contraceptive measures during andwithin 3 months after the trial; 2. Allergic constitution;have a history of allergy or allergic reactions, including test drug ingredients or any drug or food allergy or pollen hypersensitivity. IgE abnormalities; 3. Have a history of drug or drug abuse; 4. Known disease history of disease of central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, metabolic system or other significant diseases; 5. Known cancer family history; 6. Previously participation of any otherclinical 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. Previously use of any dugs, both prescrided or OTC in 14 days; 9. LVEF1.5 Upper limit of normal; Cr>N; 11. Blood routine inspection: WBC1.2 Upper limit of normal; ANC<0.8 Normal lower limit; PLT<0.8 Normal lower limit; HGB<0.8 Normal lower limit; 12. Positive result of liver surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), hepatitis C antibody (HCV-Ab), HIV andsyphilis helicoid antibody (TP Ab); 13. Anti-drug antibody (ADA) test positive; 14. Know mental illness; 15. Know postural hypotension; 16. Cigarettes intake more than 5 cigarettes per day or the same amount of tobacco; 17. 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; 18. Have a history of faint at the sight of blood or fainting during acupuncture; 19. Any other exclusion decision from investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactYi Fang
Peking University Peoples Hospital
Outcome results
None listed