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

BCD-178-1

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

2022-08-08

2023-04-30

2024-01-31

Active (not recruiting)

Early phase I

100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 100, 'type': 'ACTUAL'}}

2023-02-22