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

NCT02762799 | Completed Phase 1 Results

• 1 other identifier: BCD-002-1
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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®

Conditions

Leucocytosis

Keywords

neutrophil count; filgrastim; granulocyte colony-stimulating factor

Outcome Measures

Primary Outcomes (2)

• AUC (0-48 Hours)

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

  0 to 48 hours post-dose

• Cmax After Subcutaneous Injection

  Maximal concentration of filgrastim after subcutaneous injection of filgrastim

  0 to 48 hours post-dose

Secondary Outcomes (15)

• Cmax After Intravenous Injection

  0 to 48 hours post-dose

• Tmax After Injection

  0 to 48 hours post-dose

• Т½

  0 to 48 hours post-dose

• Kel

  0 to 48 hours post-dose

• Clearance

  0 to 48 hours post-dose

Study Arms (4)

Leucostim® --> Neupogen®, subcutaneous injections

EXPERIMENTAL

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

Biological: Leucostim®; Biological: Neupogen®

Neupogen® --> Leucostim®, subcutaneous injections

EXPERIMENTAL

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

Biological: Leucostim®; Biological: Neupogen®

Leucostim® --> Neupogen®, intravenous injections

EXPERIMENTAL

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

Biological: Leucostim®; Biological: Neupogen®

Neupogen® --> Leucostim®, intravenous injections

EXPERIMENTAL

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

Biological: Leucostim®; Biological: Neupogen®

Interventions

Leucostim® BIOLOGICAL

Leucostim® is filgrastim biosimilar.

Also known as: filgrastim

Leucostim® --> Neupogen®, intravenous injections; Leucostim® --> Neupogen®, subcutaneous injections; Neupogen® --> Leucostim®, intravenous injections; Neupogen® --> Leucostim®, subcutaneous injections

Neupogen® BIOLOGICAL

Also known as: filgrastim

Leucostim® --> Neupogen®, intravenous injections; Leucostim® --> Neupogen®, subcutaneous injections; Neupogen® --> Leucostim®, intravenous injections; Neupogen® --> Leucostim®, subcutaneous injections

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biocad: lead

MeSH Terms

Conditions

Leukocytosis

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Yulia Linkova Medical Director
• Organization: Biocad

linkova@biocad.ru

+7 (495) 992 66 28

Study Officials

• Roman Ivanov, PhD

  JCS BIOCAD

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2016
• First Posted: May 5, 2016
• Study Start: July 18, 2016
• Primary Completion: November 11, 2016
• Study Completion: November 11, 2016
• Last Updated: December 19, 2018
• Results First Posted: December 19, 2018

Record last verified: 2018-12