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Completed

NCT Number: NCT02762799

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

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®

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Key information

Conditions

Leucocytosis Hematologic Diseases Hemic and Lymphatic Diseases Leukocyte Disorders Leukocytosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Leucostim®

Biological

Leucostim® is filgrastim biosimilar.

Other names: filgrastim

Neupogen®

Biological

Other names: filgrastim

Primary outcomes

  1. AUC (0-48 Hours)

    Time frame: 0 to 48 hours post-dose

    Area Under Curve (AUC) "concentration - time" from the moment of filgrastim injection to 48 hours

  2. Cmax After Subcutaneous Injection

    Time frame: 0 to 48 hours post-dose

    Maximal concentration of filgrastim after subcutaneous injection of filgrastim

Secondary outcomes

  1. Cmax After Intravenous Injection

    Time frame: 0 to 48 hours post-dose

    Maximal concentration of filgrastim after intravenous injection of filgrastim

  2. Tmax After Injection

    Time frame: 0 to 48 hours post-dose

    Time after single injection to reach maximal concentration of filgrastim

  3. Т½

    Time frame: 0 to 48 hours post-dose

    Half-life of filgrastim after single injection of filgrastim

  4. Kel

    Time frame: 0 to 48 hours post-dose

    The elimination rate constant after single injection of filgrastim

  5. Clearance

    Time frame: 0 to 48 hours post-dose

    Clearance of filgrastim after single injection

  6. ANC-AUEC (0-336 Hours)

    Time frame: 0 to 336 hours post-dose

    Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on absolute neutrophil count (ANC)

  7. ANC-Emax

    Time frame: 0 to 336 hours post-dose

    Maximal absolute neutrophil count after single filgrastim injection

  8. CD34-AUEC (0-336 Hours)

    Time frame: 0 to 336 hours post-dose

    Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on CD-34 cells count (CD34)

  9. CD34-Emax

    Time frame: 0 to 336 hours post-dose

    Maximal absolute count of CD34-cells after single filgrastim injection

  10. Overall Frequency of Serious Adverse Events (SAE)

    Time frame: 0 to 336 hours post-dose

  11. Overall Frequency of Adverse Events (AE)

    Time frame: 0 to 336 hours post-dose

  12. Frequency of Local Reactions

    Time frame: 0 to 336 hours post-dose

  13. Frequency of AE/SAE 3-4 Grade CTCAE 4.03

    Time frame: 0 to 336 hours post-dose

    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.

  14. Frequency of Preliminary Withdrawal Due to AE/SAE

    Time frame: 0 to 336 hours post-dose

  15. Proportion of Patients With Binding or Neutralizing Antibodies to Filgrastim

    Time frame: 0 to 336 hours post-dose

    Proportion of patients who had developed binding or neutralizing antibodies to filgrastim after single injection.

Sponsors and collaborators

Lead sponsor

Biocad

Industry

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 5, 2016
Registry last updated
Dec 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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