Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers
Metastatic Breast Cancer, Metastatic Gastric Cancer
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer
Eligibility Criteria
Inclusion Criteria: Fully understand the purpose of the trial, and have a basic understanding of the pharmacological effects and possible adverse reactions of the drug under study; Voluntary written informed consent in accordance with the Helsinki Declaration; Healthy male subjects aged ≥ 18 years and ≤ 65 years; Body weight ≥ 50 kg ≤ 90 kg, body mass index ≥ 18 ≤ 28kg/m2; The system examination indicators were within the normal range, or the examination results were abnormal but the researchers judged that there was no clinical significance; Subjects agree to use reliable contraceptive methods for both themselves and their partners during the study period and for 6 months after the study drug infusion. Exclusion Criteria: History of hypertension or abnormal blood pressure at screening/baseline measurement; A history of albuminuria or albuminuria as assessed by the investigator as clinically significant; Received any antibody or protein targeting Vascular Endothelial Cell Growth Factor (VEGF) or VEGF receptors in the previous 1 year; Study the use of any biological product or live virus vaccine within 3 months prior to drug infusion, or the use of any monoclonal antibody within 12 months; Have an inherited tendency to bleed or have coagulation dysfunction, or have a history of thrombosis or bleeding; History of digestive tract perforation or digestive tract fistula; Unhealed wound ulcers or fractures, or major surgery within 2 months prior to randomization or expected to be performed during the study period or within 2 months after study completion; Use of a prescription or over-the-counter drug or nutritional supplement within the 5 half-life of the drug or nutritional supplement or within 2 weeks prior to the study drug use; Positive virology test; Known allergy to trastuzumab; Known history of allergic diseases or allergic constitution; Study the history of blood donation 3 months before drug infusion; Received any other investigational drug therapy or participated in another interventional clinical trial within 2 months prior to screening A history of alcohol or drug abuse in the 12 months prior to screening; A history of mental illness; Subjects whose spouses plan to become pregnant; The study cannot be completed according to protocol requirements during the study period; Conditions considered unsuitable for inclusion by other researchers.
Sites / Locations
- Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Trastuzumab for injection
Herceptin
4mg/kg, Single dose for intravenous infusion
4mg/kg, Single dose for intravenous infusion