The effect of multiple doses of QAX576 in patients with asthma.

• Research type

  Research Study

• Full title

  A randomised, double blind, placebo controlled, study to compare the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of intravenous administration of QAX576 in controlled or partially controlled asthma patients.

• IRAS ID

  16647

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2008-008393-30

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  This study is designed to evaluate safety and tolerability of multiple doses of intravenous QAX576 in patients with controlled or partially controlled asthma. Safety data generated will be utilized in support of later planned multiple dose studies in patients with respiratory disease(s). Approximately 30 subjects in Russia and the UK with asthma will be enrolled onto the study.Interleukin-1? (IL-13) is a chemical in the blood which is found at higher levels in patients with asthma. Therefore, a drug that blocks IL-13 may be useful to treat asthma. The study drug, QAX576, is an antibody that blocks IL-13 in animals. Subjects may get one of three doses of QAX576 (1mg/kg, 3mg/kg or 10mg/kg) or a placebo which will be given intravenously over a 2 hour period. Subjects will be required to do this on 3 occasions (3 weeks between each period)

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/30

• Date of REC Opinion

  17 Jun 2009

• REC opinion

  Favourable Opinion