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

NCT ID: NCT05738993

Last Updated: 2023-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-08
• Study Completion Date: 2024-01-31

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

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BCD-178 group

single IV infusion of BCD-178 at a dose of 420 mg

Group Type: EXPERIMENTAL

BCD-178

Intervention Type: DRUG

A single intravenous (IV) infusion at a dose of 420 mg

Perjeta Group

single IV infusion of Perjeta at a dose of 420 mg

Group Type: ACTIVE_COMPARATOR

Perjeta

Intervention Type: DRUG

A single intravenous (IV) infusion at a dose of 420 mg

Interventions

BCD-178

A single intravenous (IV) infusion at a dose of 420 mg

Intervention Type: DRUG

Perjeta

A single intravenous (IV) infusion at a dose of 420 mg

Intervention Type: DRUG

Other Intervention Names

pertuzumab; pertuzumab

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Biocad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

City Polyclinic №77

Saint Petersburg, , Russia

X7 Clinical Research

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

BCD-178-1

Identifier Type: -

Identifier Source: org_study_id