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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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 Roc

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 Summary:
Sponsor: Biocad

Current Primary Outcome:

  • AUC (0-48 hours), AUC (0-∞) [ Time Frame: 0 to 48 hours post-dose ]
    Area Under Curve (AUC) "concentration - time" from the moment of filgrastim injection to 48 hours and to infinity
  • Cmax after subcutaneous injection [ Time Frame: 0 to 48 hours post-dose ]
    Maximal concentration of filgrastim after subcutaneous injection of filgrastim


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cmax after intravenous injection [ Time Frame: 0 to 48 hours post-dose ]
    Maximal concentration of filgrastim after intravenous injection of filgrastim
  • Tmax after injection [ Time Frame: 0 to 48 hours post-dose ]
    Time after single injection to reach maximal concentration of filgrastim
  • Т½ [ Time Frame: 0 to 48 hours post-dose ]
    Half-life of filgrastim after single injection of filgrastim
  • Kel [ Time Frame: 0 to 48 hours post-dose ]
    The elimination rate constant after single injection of filgrastim
  • Clearance [ Time Frame: 0 to 48 hours post-dose ]
    Clearance of filgrastim after single injection
  • ANC-AUEC (0-336 hours) [ Time Frame: 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 [ Time Frame: 0 to 336 hours post-dose ]
    Maximal absolute neutrophil count after single filgrastim injection
  • CD34-AUEC (0-336 hours) [ Time Frame: 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 [ Time Frame: 0 to 336 hours post-dose ]
    Maximal absolute count of CD34-cells after single filgrastim injection
  • 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 [ 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 [ Time Frame: 0 to 336 hours post-dose ]
    Proportion of patients who had developed binding or neutralizing antibodies to filgrastim after single injection.


Original Secondary Outcome: Same as current

Information By: Biocad

Dates:
Date Received: April 1, 2016
Date Started: August 2016
Date Completion: February 2017
Last Updated: May 5, 2016
Last Verified: May 2016