Breast cancer
Conditions
Interventions
Experimental group:Intravenous injection of HS627
Sponsors
Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Signing the informed consent and being able to complete the test according to the plan; 2. Aged >= 18 and <= 40 (subject to the day of signing informed consent), male; 3. BMI is between 19~26 kg/m2 (including 19 kg/m2 and 26 kg/m2), and the weight is between 50-80kg (including 50kg and 80kg); 4. The left ventricular ejection fraction (LVEF) was more than 50% by echocardiography 2 weeks before drug administration; 5. During the trial period and within 6 months after the infusion, the subjects or their spouses should take appropriate and effective contraceptive measures, such as abstinence and double barrier method (such as condom and diaphragm), oral contraceptive pill and IUD placement.
Exclusion criteria
Exclusion criteria: 1. Patients with mental, respiratory, cardiovascular, digestive, urinary, reproductive, skeletal and motor diseases, blood, endocrine, nervous and other system diseases, and the judgment of the researchers has an impact on the pharmacokinetic results or safety; 2. Those who have a history of allergy to patorzumab or any of its auxiliary materials or food; or who have special requirements for diet and cannot follow the unified diet; or who have a history of specific allergy (asthma, urticaria, eczema dermatitis, etc.); or who are allergic to the apparatus (such as syringe needle or intravenous drip needle, or intravenous drip hose) needed in the test; 3. Serious bleeding factors affecting venous blood collection; 4. Patients with history of malignant tumor; 5. Having previously received any antibody treatment targeting HER2 receptor or used monoclonal antibody within 6 months before signing informed consent; 6. Vaccinated with any live vaccine within 6 months before signing the informed consent; 7. Alcoholics or regular drinkers within 3 months before the test, i.e. those who drink more than 14 units of alcohol per week (14 bottles of 360 ml beer or 630 ml spirits with 40% alcohol or 2100 ml wine), or whose alcohol breath test is positive; 8. Have used soft drugs (such as marijuana) within 3 months before signing informed consent or hard drugs within 1 year before signing the informed consent (e.g. cocaine, phencyclidine, etc.); drug abuse test positive (morphine, Amphetamine, ketamine, dimethylene dioxoamphetamine, tetrahydrocannabinolic acid); 9. Within 3 months prior to signing the informed consent, he / she had blood donation history or lost more than 400ml of blood, received blood transfusion or had used blood products;those who lost more than 200 ml blood within one month before signing the informed consent; 10. Those who have participated in other clinical trials and taken the experimental drugs or instruments within 3 months before signing the informed consent; 11. Those who are addicted to smoking or have more than 5 cigarettes per day on average within three months before signing the informed consent; 12. Those who have undergone surgery within 2 months before signing the informed consent; 13. Those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, proprietary Chinese medicine, vitamins, dietary supplements, etc.) and health care products within 14 days prior to signing the informed consent, or those who have received no more than 5 half lives of previous treatment drugs before using the experimental drugs, whichever is the longer; 14. Patients with upper respiratory tract infection or other acute infection within 2 weeks before screening; 15. Drinking too much tea, coffee and / or caffeinated drinks (more than 8 cups, 1 cup = 250 ml) every day; 16. In screening or baseline period, the researchers judged that the vital signs, physical examination and laboratory examination were abnormal with clinical significance; 17. In screening period or baseline period, the investigator judges the abnormal ECG examination with clinical significance, or QTc >= 450 ms, or with a history of clinically significant ECG abnormalities; 18. An positive results of HIV antibody, HBsAg, HCV antibody and Treponema pallidum antibody; 19. Anti drug antibody (ADA) test is positive; 20. The researcher thinks that it is not suitable to join the group or may not complete the ex
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the concentration time curve (AUC0 - 8) from 0 to infinity; | — |
Countries
China
Contacts
Public ContactYu Cao
Affiliated Hospital of Qingdao University
Outcome results
None listed