← Back to all trials
Active Not Recruiting
NCT05738993
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
Conditions: Breast Cancer
Sex: Male
Ages: 18 Years – 45 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 100
Sponsor: Biocad
Location: Russian Federation
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
Eligibility 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
Source: ClinicalTrials.gov (NCT05738993). StuddyBuddy aggregates publicly available trial information.
