breast cancer
Conditions
Interventions
A:KM118 420 mg
B:Perjeta 420 mg
Sponsors
Beijing shijitan hospital affiliated to capital medical university
Eligibility
Sex/Gender
Male
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1 male subjects aged >=18 years; 2 Weight =50kg, body mass index (BMI) between 19.0 and 26.0 kg/m^2 (inclusive); 3 Understand and voluntarily sign the informed consent form and voluntarily participate in this study; 4 Subjects agreed to use reliable contraceptive measures (such as absolute abstinence, sterilization, birth control pills, injectable contraceptive medroxyprogesterone acetate or subcutaneous implant contraception, etc.) for themselves and their partners during the study period and within 6 months after the infusion of experimental drugs; You can't use the rhythm method for contraception).
Exclusion criteria
Exclusion criteria: 1. Patients with clinically significant diseases such as heart, liver, kidney, gastrointestinal tract, gallbladder, endocrine, cardiovascular system, nerve, spirit, respiration, immunity and blood, and those with a history of serious diseases of the above organs or systems, which may endanger the safety of the subjects or affect the research results; 2. Those whose vital signs, physical examination, laboratory examination (blood routine, blood biochemistry, urine routine and blood coagulation function), 12-lead electrocardiogram examination, echocardiogram examination and chest imaging examination are abnormal and have clinical significance as judged by the researcher; There are positive results in serum virology examination (HBsAg, HCV-Ab, HIV-Ab, TP-Ab) during the screening period; 4. There is a history of food drug allergy or allergic reaction judged by the researcher to be clinically significant, and the person is allergic to pertuzumab or its auxiliary materials; 5. Patients who have undergone surgery within 4 weeks before administration, or plan to undergo surgery during the study period; 6. Those who have a history of drug abuse and drug abuse; 7. Drug abuse screening positive; 8. Have taken any prescription drugs, over-the-counter drugs, vitamin products, Chinese herbal medicines or health care products within 2 weeks before the administration of the study, and the researchers believe that this situation may affect the evaluation results of this study; Those who have been vaccinated within 3 months before administration, or those who intend to be vaccinated during the study; 10. Those who donated blood or suffered massive bleeding (=400mL) within 3 months before drug administration or planned to donate blood during the trial; 11. Those who have used HER2 or any antibody or other protein drugs targeting HER2 receptor in the past, or used any monoclonal antibody within 12 months before administration; 12. Pertuzumab ADA test was positive during screening; 13. As a subject, he has participated in any drug clinical trial and accepted the test drug within 3 months before the first drug administration in the study; 14. Those who have special requirements for diet and cannot follow the unified diet; 15. People who can't tolerate venipuncture or have a history of needle fainting or blood fainting; 16.. Those who are addicted to smoking (the average daily smoking amount is more than 5 cigarettes in the 3 months before administration) or drinking (the average weekly drinking amount is more than 28 units of alcohol in the 3 months before administration, 1 unit =285mL of beer or 25mL of spirits or 75mL of wine with 40% alcohol content); 17. Anyone who has taken any alcoholic products orally within 24 hours before administration, or who has been tested positive by alcohol breath test; 18. Disagree to avoid using alcohol, tobacco or caffeinated drinks within 24 hours before and during the trial, or avoid strenuous exercise, or avoid other factors that affect the absorption, distribution, metabolism and excretion of drugs; 19. Subjects with poor compliance or unable to comply with the relevant provisions of the research plan for personal reasons, or who are judged by the researchers to be unsuitable for participating in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| area under the concentration-time curve from time 0 to the last measurable concentration time point (AUC0–t) ; | — |
Secondary
| Measure | Time frame |
|---|---|
| peak concentration (Cmax);area under the concentration-time curve from time 0 to 8 (AUC0–8) ;observed time to Cmax (Tmax);half-life time (t1/2);Clearance rate constant (?z) ;apparent distribution volume (Vd) ;apparent clearance rate (CLz);mean residence time (MRT); | — |
Countries
China
Contacts
Public ContactWang Xinghe
Beijing shijitan hospital affiliated to capital medical university
Outcome results
None listed