A multi-center, open-label, single-arm clinical study to assess effects of a 5-day regimen of 10 micrograms per kilogram (mcg/kg) of tbo-filgrastim administered subcutaneously daily on the mobilization of cluster of differentiation 34+ (CD34+) cells in at least 60 healthy male and female participants. The pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of tbo-filgrastim will be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1
solution for subcutaneous injection
Teva Investigational Site 14029
Duarte, California, United States
Teva Investigational Site 14025
La Jolla, California, United States
Teva Investigational Site 14023
Beech Grove, Indiana, United States
Percentage of Participants With at Least 2*10^6 Cluster of Differentiation 34+ (CD34+) Cells Per Kilogram (Cells/kg) of Recipient Body Weight Collected in the First Apheresis on Day 5
The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.
Time frame: Day 5
Percentage of Participants With at Least 2*10^6 CD34+ Cells/kg of Donor Baseline Body Weight Collected After the First Apheresis on Day 5
The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.
Time frame: Day 5
Percentage of Participants With at Least 5*10^6 CD34+ Cells/kg of Recipient Body Weight Collected After the First Apheresis on Day 5
The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.
Time frame: Day 5
Number of Aphereses Necessary to Collect at Least 5*10^6 CD34+ Cells/kg of Recipient Body Weight
The measurement of CD34+ cells in the apheresis product was performed by the local laboratory according to institutional guidelines.
Time frame: Days 5 to 8
Percentage of Participants With Adverse Events (AEs)
A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module. An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs presented here included both SAEs and non-serious AEs.
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Teva Investigational Site 14026
Detroit, Michigan, United States
Teva Investigational Site 14027
Chapel Hill, North Carolina, United States
Teva Investigational Site 14030
Cincinnati, Ohio, United States
Teva Investigational Site 14033
Greenville, South Carolina, United States
Teva Investigational Site 14035
Memphis, Tennessee, United States
Teva Investigational Site 14024
San Antonio, Texas, United States
Time frame: From first administration of study drug (Day 1) up to early termination/end of study (up to approximately 3 months)
Percentage of Participants With Anti-Drug Antibodies (ADA)
Blood samples (5 milliliters \[mL\]) for analysis of ADA were obtained for all participants at timepoints described.
Time frame: Baseline (Day -3) up to early termination/end of study (up to approximately 3 months)
Maximum Observed Serum Recombinant Methionyl Human Granulocyte Colony-Stimulating Factor (r-metHuG-CSF) Concentration (Cmax)
Blood samples were drawn for all participants for the determination of serum r-metHuG-CSF concentrations on Day 4. Pharmacokinetic (PK) parameter was calculated from concentration-time data using non compartmental methods, when possible.
Time frame: Day 4 (8 hours post-dose)
Maximum Observed Peripheral CD34+ Cell Count (CD34+Cmax)
Serial blood samples for the determination of CD34+ cell count were drawn.
Time frame: Between Day 1 (pre-dose) and before the first apheresis on Day 5