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Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®

Primary Purpose

Leucocytosis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Leucostim®
Neupogen®
Sponsored by
Biocad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Leucocytosis focused on measuring neutrophil count, filgrastim, granulocyte colony-stimulating factor

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Written informed consent.
  • Male gender.
  • Age between 18 and 45 years.
  • Normal body mass index.
  • Verified diagnosis "healthy", established according to the anamnesis, physical examination and laboratory findings.
  • Absence of alcohol or drug abuse.

Exclusion Criteria:

  • History of use of filgrastim.
  • Allergy to any components of study drugs.
  • Acute hemorrhage, donation of blood / plasma or blood transfusions during last 2 months prior to enrollment in the study, history of chronic bleeding.
  • Surgical interventions during last 30 days prior to screening or planed surgical intervention during the study.
  • Any diseases that could interfere with pharmacokinetics of filgrastim, including chronic liver, liver or blood diseases, diseases of cardiovascular, lung and neuroendocrine systems.
  • Fever with body temperature higher than 40°С.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Leucostim® --> Neupogen®, subcutaneous injections

    Neupogen® --> Leucostim®, subcutaneous injections

    Leucostim® --> Neupogen®, intravenous injections

    Neupogen® --> Leucostim®, intravenous injections

    Arm Description

    Healthy volunteers in this group will receive single subcutaneous injection Leucostim® on Day 1 followed by single subcutaneous injection Leucostim® on Day 29.

    Healthy volunteers in this group will receive single subcutaneous injection Neupogen®, on Day 1 followed by single subcutaneous injection Leucostim® on Day 29.

    Healthy volunteers in this group will receive single intravenous injection Leucostim® on Day 1 followed by single intravenous injection Leucostim® on Day 29.

    Healthy volunteers in this group will receive single intravenous injection Neupogen® on Day 1 followed by single subcutaneous intravenous Leucostim® on Day 29.

    Outcomes

    Primary Outcome Measures

    AUC (0-48 Hours)
    Area Under Curve (AUC) "concentration - time" from the moment of filgrastim injection to 48 hours
    Cmax After Subcutaneous Injection
    Maximal concentration of filgrastim after subcutaneous injection of filgrastim

    Secondary Outcome Measures

    Cmax After Intravenous Injection
    Maximal concentration of filgrastim after intravenous injection of filgrastim
    Tmax After Injection
    Time after single injection to reach maximal concentration of filgrastim
    Т½
    Half-life of filgrastim after single injection of filgrastim
    Kel
    The elimination rate constant after single injection of filgrastim
    Clearance
    Clearance of filgrastim after single injection
    ANC-AUEC (0-336 Hours)
    Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on absolute neutrophil count (ANC)
    ANC-Emax
    Maximal absolute neutrophil count after single filgrastim injection
    CD34-AUEC (0-336 Hours)
    Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on CD-34 cells count (CD34)
    CD34-Emax
    Maximal absolute count of CD34-cells after single filgrastim injection
    Overall Frequency of Serious Adverse Events (SAE)
    Overall Frequency of Adverse Events (AE)
    Frequency of Local Reactions
    Frequency of AE/SAE 3-4 Grade CTCAE 4.03
    Grading scale of CTCAE 4.03 Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL (activities of daily living). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
    Frequency of Preliminary Withdrawal Due to AE/SAE
    Proportion of Patients With Binding or Neutralizing Antibodies to Filgrastim
    Proportion of patients who had developed binding or neutralizing antibodies to filgrastim after single injection.

    Full Information

    First Posted
    April 1, 2016
    Last Updated
    December 17, 2018
    Sponsor
    Biocad
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02762799
    Brief Title
    Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®
    Official Title
    Single-center Open Randomized Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® (JSC "BIOCAD", Russia) Compared to Neupogen® (F. Hoffman-La Roche Ltd., Switzerland)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 18, 2016 (Actual)
    Primary Completion Date
    November 11, 2016 (Actual)
    Study Completion Date
    November 11, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Biocad

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    BCD-002-1 is 1 phase clinical trial to evaluate pharmacokinetics, pharmacodynamics and safety of single-injection of Leucostim® to healthy volunteers compared to Neupogen®

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leucocytosis
    Keywords
    neutrophil count, filgrastim, granulocyte colony-stimulating factor

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Leucostim® --> Neupogen®, subcutaneous injections
    Arm Type
    Experimental
    Arm Description
    Healthy volunteers in this group will receive single subcutaneous injection Leucostim® on Day 1 followed by single subcutaneous injection Leucostim® on Day 29.
    Arm Title
    Neupogen® --> Leucostim®, subcutaneous injections
    Arm Type
    Experimental
    Arm Description
    Healthy volunteers in this group will receive single subcutaneous injection Neupogen®, on Day 1 followed by single subcutaneous injection Leucostim® on Day 29.
    Arm Title
    Leucostim® --> Neupogen®, intravenous injections
    Arm Type
    Experimental
    Arm Description
    Healthy volunteers in this group will receive single intravenous injection Leucostim® on Day 1 followed by single intravenous injection Leucostim® on Day 29.
    Arm Title
    Neupogen® --> Leucostim®, intravenous injections
    Arm Type
    Experimental
    Arm Description
    Healthy volunteers in this group will receive single intravenous injection Neupogen® on Day 1 followed by single subcutaneous intravenous Leucostim® on Day 29.
    Intervention Type
    Biological
    Intervention Name(s)
    Leucostim®
    Other Intervention Name(s)
    filgrastim
    Intervention Description
    Leucostim® is filgrastim biosimilar.
    Intervention Type
    Biological
    Intervention Name(s)
    Neupogen®
    Other Intervention Name(s)
    filgrastim
    Primary Outcome Measure Information:
    Title
    AUC (0-48 Hours)
    Description
    Area Under Curve (AUC) "concentration - time" from the moment of filgrastim injection to 48 hours
    Time Frame
    0 to 48 hours post-dose
    Title
    Cmax After Subcutaneous Injection
    Description
    Maximal concentration of filgrastim after subcutaneous injection of filgrastim
    Time Frame
    0 to 48 hours post-dose
    Secondary Outcome Measure Information:
    Title
    Cmax After Intravenous Injection
    Description
    Maximal concentration of filgrastim after intravenous injection of filgrastim
    Time Frame
    0 to 48 hours post-dose
    Title
    Tmax After Injection
    Description
    Time after single injection to reach maximal concentration of filgrastim
    Time Frame
    0 to 48 hours post-dose
    Title
    Т½
    Description
    Half-life of filgrastim after single injection of filgrastim
    Time Frame
    0 to 48 hours post-dose
    Title
    Kel
    Description
    The elimination rate constant after single injection of filgrastim
    Time Frame
    0 to 48 hours post-dose
    Title
    Clearance
    Description
    Clearance of filgrastim after single injection
    Time Frame
    0 to 48 hours post-dose
    Title
    ANC-AUEC (0-336 Hours)
    Description
    Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on absolute neutrophil count (ANC)
    Time Frame
    0 to 336 hours post-dose
    Title
    ANC-Emax
    Description
    Maximal absolute neutrophil count after single filgrastim injection
    Time Frame
    0 to 336 hours post-dose
    Title
    CD34-AUEC (0-336 Hours)
    Description
    Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on CD-34 cells count (CD34)
    Time Frame
    0 to 336 hours post-dose
    Title
    CD34-Emax
    Description
    Maximal absolute count of CD34-cells after single filgrastim injection
    Time Frame
    0 to 336 hours post-dose
    Title
    Overall Frequency of Serious Adverse Events (SAE)
    Time Frame
    0 to 336 hours post-dose
    Title
    Overall Frequency of Adverse Events (AE)
    Time Frame
    0 to 336 hours post-dose
    Title
    Frequency of Local Reactions
    Time Frame
    0 to 336 hours post-dose
    Title
    Frequency of AE/SAE 3-4 Grade CTCAE 4.03
    Description
    Grading scale of CTCAE 4.03 Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE: Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL (activities of daily living). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
    Time Frame
    0 to 336 hours post-dose
    Title
    Frequency of Preliminary Withdrawal Due to AE/SAE
    Time Frame
    0 to 336 hours post-dose
    Title
    Proportion of Patients With Binding or Neutralizing Antibodies to Filgrastim
    Description
    Proportion of patients who had developed binding or neutralizing antibodies to filgrastim after single injection.
    Time Frame
    0 to 336 hours post-dose

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Written informed consent. Male gender. Age between 18 and 45 years. Normal body mass index. Verified diagnosis "healthy", established according to the anamnesis, physical examination and laboratory findings. Absence of alcohol or drug abuse. Exclusion Criteria: History of use of filgrastim. Allergy to any components of study drugs. Acute hemorrhage, donation of blood / plasma or blood transfusions during last 2 months prior to enrollment in the study, history of chronic bleeding. Surgical interventions during last 30 days prior to screening or planed surgical intervention during the study. Any diseases that could interfere with pharmacokinetics of filgrastim, including chronic liver, liver or blood diseases, diseases of cardiovascular, lung and neuroendocrine systems. Fever with body temperature higher than 40°С.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Roman Ivanov, PhD
    Organizational Affiliation
    JCS BIOCAD
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®

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