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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: BCD-178; Drug: Perjeta

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Contacts and Locations

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 192177
    • City Polyclinic №77
  • Saint Petersburg, Russian Federation, 194214
    • X7 Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Biocad

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Estimate): February 22, 2023

Study Record Updates

• Last Update Posted (Estimate): February 22, 2023
• Last Update Submitted That Met QC Criteria: February 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Pertuzumab
• Other Study ID Numbers: BCD-178-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No