Metastatic Breast Cancer
Conditions
Interventions
one:HLV02
Sponsors
First Hospital of Jilin University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary informed consent; 2. Healthy Chinese men (defined as health history, physical examination, vital signs, chest X-ray, 12-lead ECG and laboratory tests were found to have clinically significant abnormalities in); 3. Aged from 18 to 45 years; 4. Body mass index (BMI) from 19 to 28 kg/m2; 5. Weight 50 to 80 kg; 6. 14 days prior to randomization detected by echocardiography, LVEF within normal range; 7. Immunogenic [drug-resistant (anti-trastuzumab) antibody (ADA)] tested negative; 8. Subjects agreed with him and his spouse or partner after the study medication within three months to study the use of reliable contraception use from the beginning, or the subject does not have fertility; 9. Do not smoke or screening within the first three months of daily smoking less than 5, do not drink or screening the first six months of weekly alcohol is less than 14 units of alcohol (1 unit of alcohol = 360 mL or 45 mL of beer alcohol content of 40 % of spirits or wine 150 mL).
Exclusion criteria
Exclusion criteria: 1. Complicated with hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, liver, mental, neurological, cancer and other serious illness or any clinical history of allergic diseases; 2. Within the first 6 months of the study drug used monoclonal antibodies or any biological agents; 3. Have a history of allergy or allergic reactions, including allergies or allergic reactions in clinical studies of any drug or drug excipients produced; 4. Use of prescription or non-prescription drugs, or dietary supplements, and the use of time within 5 half-lives of the drug or nutraceutical research or drug use before 2 weeks (time limited to whichever is longer); 5. Chinese medicine Health Products required 28 days prior to study drug discontinued; 6. Use of research has a history of blood donation within the first 3 months of medication; 7. Before using the study medication within three months participated in any other clinical study; 8. Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody positive Treponema pallidum; 9. Have a history of drug abuse; 10. The researchers could not determine to follow program requirements, instructions and study restrictions, such as uncooperative attitude, unable to return to the center to do research or follow-up visits throughout the clinical study can not be completed and so on.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| blood pressure; | — |
Countries
China
Contacts
Public ContactYanhua Ding
Outcome results
None listed