Clinical trial NCT02762799: Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leucocytosis
Keywords: neutrophil count
filgrastim
granulocyte colony-stimulating factor
Lead sponsor: Biocad
Sponsor class: INDUSTRY
First posted: 2016-05-05
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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®


Eligibility criteria: 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.

Primary outcomes:
measure: AUC (0-48 Hours)
timeFrame: 0 to 48 hours post-dose
measure: Cmax After Subcutaneous Injection
timeFrame: 0 to 48 hours post-dose
Secondary outcomes:
measure: Cmax After Intravenous Injection
timeFrame: 0 to 48 hours post-dose
measure: Tmax After Injection
timeFrame: 0 to 48 hours post-dose
measure: Т½
timeFrame: 0 to 48 hours post-dose
measure: Kel
timeFrame: 0 to 48 hours post-dose
measure: Clearance
timeFrame: 0 to 48 hours post-dose
measure: ANC-AUEC (0-336 Hours)
timeFrame: 0 to 336 hours post-dose
measure: ANC-Emax
timeFrame: 0 to 336 hours post-dose
measure: CD34-AUEC (0-336 Hours)
timeFrame: 0 to 336 hours post-dose
measure: CD34-Emax
timeFrame: 0 to 336 hours post-dose
measure: Overall Frequency of Serious Adverse Events (SAE)
timeFrame: 0 to 336 hours post-dose
measure: Overall Frequency of Adverse Events (AE)
timeFrame: 0 to 336 hours post-dose
measure: Frequency of Local Reactions
timeFrame: 0 to 336 hours post-dose
measure: Frequency of AE/SAE 3-4 Grade CTCAE 4.03
timeFrame: 0 to 336 hours post-dose
measure: Frequency of Preliminary Withdrawal Due to AE/SAE
timeFrame: 0 to 336 hours post-dose
measure: Proportion of Patients With Binding or Neutralizing Antibodies to Filgrastim
timeFrame: 0 to 336 hours post-dose
Other outcomes:
Locations:
Study officials:
affiliation: JCS BIOCAD
name: Roman Ivanov, PhD
role: STUDY_CHAIR
References: