Clinical Trial to Evaluate Pharmacokinetics, Pharmacodynamics and Safety of Leucostim® Compared to Neupogen®
- Conditions
- Leucocytosis
- Interventions
- Biological: Leucostim®Biological: Neupogen®
- Registration Number
- NCT02762799
- Lead Sponsor
- Biocad
- 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®
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Leucostim® --> Neupogen®, subcutaneous injections Neupogen® Healthy volunteers in this group will receive single subcutaneous injection Leucostim® on Day 1 followed by single subcutaneous injection Leucostim® on Day 29. Neupogen® --> Leucostim®, subcutaneous injections Neupogen® Healthy volunteers in this group will receive single subcutaneous injection Neupogen®, on Day 1 followed by single subcutaneous injection Leucostim® on Day 29. Neupogen® --> Leucostim®, intravenous injections Neupogen® Healthy volunteers in this group will receive single intravenous injection Neupogen® on Day 1 followed by single subcutaneous intravenous Leucostim® on Day 29. Leucostim® --> Neupogen®, intravenous injections Leucostim® Healthy volunteers in this group will receive single intravenous injection Leucostim® on Day 1 followed by single intravenous injection Leucostim® on Day 29. Leucostim® --> Neupogen®, intravenous injections Neupogen® Healthy volunteers in this group will receive single intravenous injection Leucostim® on Day 1 followed by single intravenous injection Leucostim® on Day 29. Leucostim® --> Neupogen®, subcutaneous injections Leucostim® Healthy volunteers in this group will receive single subcutaneous injection Leucostim® on Day 1 followed by single subcutaneous injection Leucostim® on Day 29. Neupogen® --> Leucostim®, subcutaneous injections Leucostim® Healthy volunteers in this group will receive single subcutaneous injection Neupogen®, on Day 1 followed by single subcutaneous injection Leucostim® on Day 29. Neupogen® --> Leucostim®, intravenous injections Leucostim® Healthy volunteers in this group will receive single intravenous injection Neupogen® on Day 1 followed by single subcutaneous intravenous Leucostim® on Day 29.
- Primary Outcome Measures
Name Time Method AUC (0-48 Hours) 0 to 48 hours post-dose Area Under Curve (AUC) "concentration - time" from the moment of filgrastim injection to 48 hours
Cmax After Subcutaneous Injection 0 to 48 hours post-dose Maximal concentration of filgrastim after subcutaneous injection of filgrastim
- Secondary Outcome Measures
Name Time Method Frequency of AE/SAE 3-4 Grade CTCAE 4.03 0 to 336 hours post-dose Grading scale of CTCAE 4.03
Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5 with unique clinical descriptions of severity for each AE:
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental ADL (activities of daily living).
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.Cmax After Intravenous Injection 0 to 48 hours post-dose Maximal concentration of filgrastim after intravenous injection of filgrastim
Т½ 0 to 48 hours post-dose Half-life of filgrastim after single injection of filgrastim
Overall Frequency of Adverse Events (AE) 0 to 336 hours post-dose Tmax After Injection 0 to 48 hours post-dose Time after single injection to reach maximal concentration of filgrastim
Kel 0 to 48 hours post-dose The elimination rate constant after single injection of filgrastim
Frequency of Local Reactions 0 to 336 hours post-dose Frequency of Preliminary Withdrawal Due to AE/SAE 0 to 336 hours post-dose Proportion of Patients With Binding or Neutralizing Antibodies to Filgrastim 0 to 336 hours post-dose Proportion of patients who had developed binding or neutralizing antibodies to filgrastim after single injection.
Clearance 0 to 48 hours post-dose Clearance of filgrastim after single injection
ANC-AUEC (0-336 Hours) 0 to 336 hours post-dose Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on absolute neutrophil count (ANC)
ANC-Emax 0 to 336 hours post-dose Maximal absolute neutrophil count after single filgrastim injection
CD34-AUEC (0-336 Hours) 0 to 336 hours post-dose Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on CD-34 cells count (CD34)
CD34-Emax 0 to 336 hours post-dose Maximal absolute count of CD34-cells after single filgrastim injection
Overall Frequency of Serious Adverse Events (SAE) 0 to 336 hours post-dose