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®
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
Leucostim® is filgrastim biosimilar.
AUC (0-48 Hours)
Area Under Curve (AUC) "concentration - time" from the moment of filgrastim injection to 48 hours
Time frame: 0 to 48 hours post-dose
Cmax After Subcutaneous Injection
Maximal concentration of filgrastim after subcutaneous injection of filgrastim
Time frame: 0 to 48 hours post-dose
Cmax After Intravenous Injection
Maximal concentration of filgrastim after intravenous injection of filgrastim
Time frame: 0 to 48 hours post-dose
Tmax After Injection
Time after single injection to reach maximal concentration of filgrastim
Time frame: 0 to 48 hours post-dose
Т½
Half-life of filgrastim after single injection of filgrastim
Time frame: 0 to 48 hours post-dose
Kel
The elimination rate constant after single injection of filgrastim
Time frame: 0 to 48 hours post-dose
Clearance
Clearance of filgrastim after single injection
Time frame: 0 to 48 hours post-dose
ANC-AUEC (0-336 Hours)
Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on absolute neutrophil count (ANC)
Time frame: 0 to 336 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ANC-Emax
Maximal absolute neutrophil count after single filgrastim injection
Time frame: 0 to 336 hours post-dose
CD34-AUEC (0-336 Hours)
Area Under Effect Curve (AUEC) "effect - time" from the moment of filgrastim injection to 336 hours based on CD-34 cells count (CD34)
Time frame: 0 to 336 hours post-dose
CD34-Emax
Maximal absolute count of CD34-cells after single filgrastim injection
Time frame: 0 to 336 hours post-dose
Overall Frequency of Serious Adverse Events (SAE)
Time frame: 0 to 336 hours post-dose
Overall Frequency of Adverse Events (AE)
Time frame: 0 to 336 hours post-dose
Frequency of Local Reactions
Time frame: 0 to 336 hours post-dose
Frequency of AE/SAE 3-4 Grade CTCAE 4.03
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.
Time frame: 0 to 336 hours post-dose
Frequency of Preliminary Withdrawal Due to AE/SAE
Time frame: 0 to 336 hours post-dose
Proportion of Patients With Binding or Neutralizing Antibodies to Filgrastim
Proportion of patients who had developed binding or neutralizing antibodies to filgrastim after single injection.
Time frame: 0 to 336 hours post-dose