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

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)

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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®