| Eligibility |
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 20~25 kg/m2 (including 20 kg/m2 and 25 kg/m2), and the weight is
between 50-70kg (including 50kg and 70kg);
- 4. The left ventricular ejection fraction (LVEF) was more than 50% by echocardiography
within 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:
- 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 pertuzumab or any of its auxiliary materials
or food; 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.Those who have special requirements for diet and cannot follow the unified diet;
- 4.Serious bleeding factors affecting peripheral venous blood collection;
- 5. Patients with history of malignancy;
- 6. Having previously received any antibody treatment targeting HER2 receptor or used
monoclonal antibody within 6 months before signing informed consent;
- 7. Vaccinated with any live vaccine within 6 months before signing the informed
consent;
- 8. 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 breath alcohol test is positive;
- 9. 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);
- 10. Within 3 months prior to signing the informed consent, he 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;
- 11. Those who have participated in other clinical trials and used the experimental
drugs or instruments within 3 months before signing the informed consent;
- 12. Those who are addicted to smoking or have more than 5 cigarettes per day on
average within three months before signing the informed consent;
- 13. Those who have undergone surgery within 2 months before signing the informed
consent;
- 14. 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 whose previous treatment drug(s) is(are) still within 5
half-lives when using the experimental drugs;
- 15. Patients with upper respiratory tract infection or other acute infections within 2
weeks before screening;
- 16. Drinking too much tea, coffee and / or caffeinated drinks (more than 8 cups, 1 cup
= 250 ml) every day;
- 17. In screening or baseline period, the researchers judge that the vital signs,
physical examination and laboratory examination were abnormal with clinical
significance;
- 18. In screening period or baseline period, the investigator judges the ECG be
clinically significantly abnormal, or QTc >= 450 ms, or with a history of clinically
significant ECG abnormalities;
- 19. Any positive result of HIV antibody, HBsAg, HCV antibody and Treponema pallidum
antibody;
- 20. Anti-drug antibody (ADA) test is positive;
- 21. The researcher thinks whoever is not suitable to join the group or may not be able
to complete the trial due to other reasons;
- 22. Researchers, staff of research centers, sponsors and employees or related
personnel of contract research organizations.
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