PK & PD of USV PEG-Filgrastim and Neulasta® in HVs (QBR112694)

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Two Treatment, two period, two sequence, Crossover Study to Compare the Pharmacodynamics and Pharmacokinetics of a Single Subcutaneous Injection of USV PEG-Filgrastim and Neulasta® to Healthy Male and Female Subjects

• IRAS ID

  111957

• Contact name

  Stuart Mair

• Sponsor organisation

  USV Ltd

• Eudract number

  2012-003060-45

• Research summary

  The Sponsor is developing the study drug, USV PEG-Filgrastim, for use in the potential treatment of low white blood cells and associated fever, in chemotherapy patients. The study will aim to compare the pharmacokinetics (how well the drug is absorbed into the bloodstream) and the pharmacodynamics (the effect of the drug on the body in terms of increasing the production of neutrophiles - a type of white blood cell) of the study drug with the marketed medicinal product comparator, Neulasta©. The study will also aim to gather further safety and tolerability data. This study will involve the administration of single subcutaneous (under the skin) injections of 6 mg of both USV PEG-Filgrastim and Neulasta© to healthy male and female subjects over 2 study periods, in a 2 way cross-over design.

• REC name

  HSC REC A

• REC reference

  12/NI/0130

• Date of REC Opinion

  10 Sep 2012

• REC opinion

  Further Information Favourable Opinion