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

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)

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®

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.