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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

Sponsor
Biocad (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05738993
Collaborator
(none)
100
Enrollment
2
Locations
2
Arms
17.8
Anticipated Duration (Months)
50
Patients Per Site
2.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Aug 8, 2022
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Jan 31, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Cmax [pre-dose to day 91, 23 timepoints]

      maximum observed plasma concentration of the drug

    2. Tmax [pre-dose to day 91, 23 timepoints]

      time from administration to maximum observed plasma concentration of the drug

    3. T½ [pre-dose to day 91, 23 timepoints]

      Elimination half-life

    4. Kel [pre-dose to day 91, 23 timepoints]

      elimination rate constant

    5. CL [pre-dose to day 91, 23 timepoints]

      total clearance

    6. Vd [pre-dose to day 91, 23 timepoints]

      volume of distribution

    7. safety assessment [Day 1 to day 91]

      frequency, severity, and profile of adverse events

    8. immunogenicity assessment [pre-dose to day 91, 5 timepoints]

      binding anti-drug antibodies (BAb) and neutralizing anti-drug antibodies (NAb)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 City Polyclinic №77 Saint Petersburg Russian Federation 192177
    2 X7 Clinical Research Saint Petersburg Russian Federation 194214

    Sponsors and Collaborators

    • Biocad

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Biocad
    ClinicalTrials.gov Identifier:
    NCT05738993
    Other Study ID Numbers:
    • BCD-178-1
    First Posted:
    Feb 22, 2023
    Last Update Posted:
    Feb 22, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pertuzumab

    Study Results

    No Results Posted as of Feb 22, 2023