NCT05738993
Active, not recruiting
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- BCD-178
- Conditions
- Breast Cancer
- Sponsor
- Biocad
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- AUC0-∞
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief 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
Investigators
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
Arms & Interventions
BCD-178 group
single IV infusion of BCD-178 at a dose of 420 mg
Intervention: BCD-178
Perjeta Group
single IV infusion of Perjeta at a dose of 420 mg
Intervention: Perjeta
Outcomes
Primary Outcomes
AUC0-∞
Time Frame: pre-dose to day 91, 23 timepoints
Area under the concentration-time curve of the drug over the time interval from zero to infinity
Secondary Outcomes
- Cmax(pre-dose to day 91, 23 timepoints)
- Tmax(pre-dose to day 91, 23 timepoints)
- T½(pre-dose to day 91, 23 timepoints)
- CL(pre-dose to day 91, 23 timepoints)
- Kel(pre-dose to day 91, 23 timepoints)
- Vd(pre-dose to day 91, 23 timepoints)
- safety assessment(Day 1 to day 91)
- immunogenicity assessment(pre-dose to day 91, 5 timepoints)
Study Sites (2)
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