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