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

Study Overview
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Brief Summary
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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

Official Title
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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
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Breast Cancer

Intervention / Treatment
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* Drug: BCD-178
* Drug: Perjeta


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCD-178 group<br>single IV infusion of BCD-178 at a dose of 420 mg | Drug: BCD-178<br>* A single intravenous (IV) infusion at a dose of 420 mg<br>* Other names: pertuzumab;|
| Active Comparator: Perjeta Group<br>single IV infusion of Perjeta at a dose of 420 mg | Drug: Perjeta<br>* A single intravenous (IV) infusion at a dose of 420 mg<br>* Other names: pertuzumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC0-∞ | Area under the concentration-time curve of the drug over the time interval from zero to infinity | pre-dose to day 91, 23 timepoints | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | maximum observed plasma concentration of the drug | pre-dose to day 91, 23 timepoints | 
| Tmax | time from administration to maximum observed plasma concentration of the drug | pre-dose to day 91, 23 timepoints | 
| T½ | Elimination half-life | pre-dose to day 91, 23 timepoints | 
| Kel | elimination rate constant | pre-dose to day 91, 23 timepoints | 
| CL | total clearance | pre-dose to day 91, 23 timepoints | 
| Vd | volume of distribution | pre-dose to day 91, 23 timepoints | 
| safety assessment | frequency, severity, and profile of adverse events | Day 1 to day 91 | 
| immunogenicity assessment | binding anti-drug antibodies (BAb) and neutralizing anti-drug antibodies (NAb) | pre-dose to day 91, 5 timepoints |