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

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Biocad

Status and phase

Completed
Phase 1

Conditions

Leucocytosis

Treatments

Biological: Neupogen®
Biological: Leucostim®

Study type

Interventional

Funder types

Industry

Identifiers

NCT02762799
BCD-002-1

Details and patient eligibility

About

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®

Enrollment

60 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

60 participants in 4 patient groups

Leucostim® --> Neupogen®, subcutaneous injections
Experimental group
Description:
Healthy volunteers in this group will receive single subcutaneous injection Leucostim® on Day 1 followed by single subcutaneous injection Leucostim® on Day 29.
Treatment:
Biological: Leucostim®
Biological: Neupogen®
Neupogen® --> Leucostim®, subcutaneous injections
Experimental group
Description:
Healthy volunteers in this group will receive single subcutaneous injection Neupogen®, on Day 1 followed by single subcutaneous injection Leucostim® on Day 29.
Treatment:
Biological: Leucostim®
Biological: Neupogen®
Leucostim® --> Neupogen®, intravenous injections
Experimental group
Description:
Healthy volunteers in this group will receive single intravenous injection Leucostim® on Day 1 followed by single intravenous injection Leucostim® on Day 29.
Treatment:
Biological: Leucostim®
Biological: Neupogen®
Neupogen® --> Leucostim®, intravenous injections
Experimental group
Description:
Healthy volunteers in this group will receive single intravenous injection Neupogen® on Day 1 followed by single subcutaneous intravenous Leucostim® on Day 29.
Treatment:
Biological: Leucostim®
Biological: Neupogen®

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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