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

Phase 1

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Drug: BCD-178; Drug: Perjeta

• Registration Number: NCT05738993
• Lead Sponsor: Biocad

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-08
• Status Verified: 2023-02
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-02-13
• Last Update Submitted: 2023-02-13
• Study First Posted: 2023-02-22
• Last Update Posted: 2023-02-22
• Primary Completion: 2023-04-30
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BCD-178 group	BCD-178	single IV infusion of BCD-178 at a dose of 420 mg
Perjeta Group	Perjeta	single IV infusion of Perjeta at a dose of 420 mg

Primary Outcome Measures

Name	Time	Method
AUC0-∞	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 Outcome Measures

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

Trial Locations

Locations (2)

City Polyclinic №77; 🇷🇺 Saint Petersburg, Russian Federation

X7 Clinical Research; 🇷🇺 Saint Petersburg, Russian Federation