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

• Status: Active, not recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Biocad
• Treatments: Pertuzumab

Criteria

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