A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers

A Double-Blind, Comparative, Randomized Clinical Study of the Pharmacokinetics, Safety, and Immunogenicity of a Single Intravenous Infusion of BCD-178 or Perjeta® in Healthy Volunteers

This is a double-blind, comparative, randomized phase I study comparing pharmacokinetics, safety and immunogenicity profiles of a biosimilar pertuzumab (BCD-178) and Perjeta after a single intravenous infusion in healthy male volunteers

Inclusion Criteria:

• Signed informed consent;
• Men aged 18-45 years;
• Body mass index (BMI) in the range of 18.5 30.0 kg/m2;
• The confirmed "healthy" status;
• Left ventricular ejection fraction (LVEF) > 50 % based on the results of EchoCG at screening;
• Willingness of the volunteers and their sexual partners of childbearing potential to use reliable methods of contraception, starting from signing the informed consent form, during the study, and for 6 months after the drug administration;

Exclusion Criteria:

• Known allergy or intolerance to monoclonal antibody products (murine, chimeric, humanized, fully human) or any other components of the study drugs;
• Values of standard laboratory and instrumental parameters exceeding the normal limits accepted at the study site;
• History or evidence of any chronic disease