Breast cancer
Conditions
Interventions
Experimental group 1:HS627(210mg/7ml)i.v.
Experimental group 2:HS627(420mg/14ml)i.v.
Sponsors
Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Those who have signed informed consent and can complete the experiment according to the plan; 2. Aged 18-40 years (as of the date of signing the informed consent), male; 3. Subjects with body mass index (BMI) between 20 and 25kg/m^2 (including 20kg/m2 and 25kg/ m2) and body weight between 50 and 70kg (including 50 and 70kg); 4. The left ventricular ejection fraction (LVEF) was > 50% by echocardiography within 2 weeks before administration of the test drug; 5. During the trial period and for 6 months after the end of the infusion, the subject or his or her spouse will use appropriate and effective contraceptive methods, such as abstinence and the dual barrier method (e.g., condom and diaphragm), the spouse's oral contraceptive, and the placement of an IUD.
Exclusion criteria
Exclusion criteria: 1. Patients with mental, respiratory, cardiovascular, digestive, urinary, reproductive, skeletal and exercise, blood, endocrine, nervous and other system diseases, and researchers judge that the pharmacokinetic results or safety of drugs will be affected; 2. Previous history of pertuzumab or any of its excipients or food allergy; Or a history of specific allergic reactions (asthma, urticaria, eczema dermatitis, etc.); Or allergic to the instruments (such as syringes or intravenous needles, or intravenous tubes) used in the test; 3. Have special requirements on diet and cannot comply with the unified diet; 4. Severe bleeding factors affecting venous blood collection; 5. Patients with a history of malignant tumor; 6. Those who have received any antibody therapy targeting HER2 receptor in the past or have used monoclonal antibody within 6 months before signing the informed consent; 7. Those who have received any live vaccine within 6 months before signing the informed consent; 8. Heavy drinkers or regular drinkers in the three months prior to the trial, i.e. those who drink more than 14 units of alcohol per week (14 bottles of 360 mL beer or 630mL spirits with 40% alcohol or 2100mL wine), or who test positive for alcohol breath tests; 9. Used soft drugs (such as marijuana) within 3 months or hard drugs (such as cocaine, PCP, etc.) within 1 year before signing the informed consent; Positive test results for drug abuse (morphine, methamphetamine, ketamine, dimethylene dioxyamphetamine, THC); 10. Have a history of blood donation or blood loss of more than 400 mL, received blood transfusion or used blood products within 3 months before signing the informed consent; Blood loss of more than 200mL within 1 month before signing the informed consent; 11. Participating in other clinical trials and taking experimental drugs or using experimental devices within 3 months prior to signing the informed consent; 12. Smokers who smoked more than 5 cigarettes per day in the 3 months before signing the informed consent; 13. Patients who have received surgical operations within 2 months before signing the informed consent; 14. Patients who have received any drug treatment (including prescription drugs, non-prescription drugs, biological products, Chinese patent medicines, vitamins, dietary supplements, etc.) or health care products within 14 days before signing the informed consent, or before using the experimental drugs, the previous treatment drugs have not passed 5 half-lives, whichever is longer; 15. Upper respiratory tract infections or other acute infections within 2 weeks prior to screening; 16. Excessive consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 mL) per day; 17. During the screening period or baseline period, researchers judged that the abnormal vital signs, physical examination and laboratory examination were clinically significant; 18. In the screening period or baseline period, patients with clinically significant ECG abnormalities, or QTc>= 450 ms, or patients with a history of clinically significant ECG abnormalities; 19. Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody test any positive result; 20. Drug resistant antibody (ADA) positive; 21. Those who the researcher thinks are not suitable for inclusion or may not be able to complete the study for other reasons; 22. Employees or associated personnel of
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration time curve (AUC0 - 8) from 0 to infinity; | — |
Countries
China
Contacts
Public ContactCao Yu
Outcome results
None listed