Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers

Phase I Clinical Study of Randomized, Double-blind, Single-dose, Parallel Comparison of Trastuzumab for Injection and Herceptin® in Healthy Male Volunteers on Pharmacokinetics and Safety

Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells. A randomized, double-blind, single-dose, parallel phase I study comparing trastuzumab for injection with Herceptin ® in healthy male volunteers was conducted to evaluate the similarities in pharmacokinetics, tolerability, safety and immunogenicity of Trastuzumab for injection and Herceptin®.

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.