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

NCT05738993 | Unknown Phase 1

• 1 other identifier: BCD-178-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Cmax

  pre-dose to day 91, 23 timepoints

• Tmax

  pre-dose to day 91, 23 timepoints

• T½

  pre-dose to day 91, 23 timepoints

• Kel

  pre-dose to day 91, 23 timepoints

• CL

  pre-dose to day 91, 23 timepoints

Study Arms (2)

BCD-178 group

EXPERIMENTAL

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

Drug: BCD-178

Perjeta Group

ACTIVE COMPARATOR

single IV infusion of Perjeta at a dose of 420 mg

Drug: Perjeta

Interventions

BCD-178 DRUG

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

Also known as: pertuzumab

BCD-178 group

Perjeta DRUG

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

Also known as: pertuzumab

Perjeta Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Biocad: lead

Study Sites (2)

City Polyclinic №77

Saint Petersburg, 192177, Russia

Location

X7 Clinical Research

Saint Petersburg, 194214, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

pertuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 22, 2023
• Study Start: August 8, 2022
• Primary Completion: April 30, 2023
• Study Completion: January 31, 2024
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

RU (2)