To investigate the effects of MAD 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 Multiple Ascending Inhaled Doses of AZD2115 in Healthy Male Subjects

• IRAS ID

  89281

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2011-002402-75

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• 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 second time this drug will be given to human volunteers. The purpose of this research study is to evaluate safety and tolerability of AZD2115 (when given as a single dose as well as in multiple ascending doses) and how much AZD2115 enters the blood circulation. We are also investigating what it is broken down into, when given by inhalation and how much of the drug is cleared from the body. The study will take place at Quintiles Drug Research Unit at Guy??s Hospital, Quintiles Ltd. The study will involve up to 4 groups of 9 volunteers. Volunteers will receive a single dose of AZD2115 or placebo (dummy) initially, followed by daily doses for 14 days starting 72 hours after the first administration of the study drug. There will be 3 visits to the unit, including a residential visit lasting 19 nights/20 days.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  11/IE/0125

• Date of REC Opinion

  18 Oct 2011

• REC opinion

  Further Information Favourable Opinion