To investigate the effects of AZD2115

• Research type

  Research Study

• Full title

  A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AZD2115 after Single Ascending Doses in Healthy Male Subjects

• IRAS ID

  70197

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2010-020720-22

• Research summary

  The drug being tested in this study, AZD2115, is being developed for the possible treatment of chronic obstructive pulmonary disease (COPD).This will be the first time this drug will be given to human volunteers. This study plans to investigate the tolerability, safety and how much of the drug enters the blood circulation by collecting blood and urine samples. The study will take place at Quintiles Drug research Unit at Guy's Hospital, Quintiles Ltd. Approximately 80 volunteers, in 10 groups of 8 each, will participate in the trial. Each volunteer will attend the unit for a single admission lasting 4 days, during which time they will receive AZD2115 on one occasion.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC07/26

• Date of REC Opinion

  17 Jan 2011

• REC opinion

  Further Information Favourable Opinion