To assess safety/tolerability and PK/PD of a SAD AZD8848

• Research type

  Research Study

• Full title

  A double-blind, placebo-controlled, randomised study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending inhaled doses of AZD8848 in healthy subjects.

• IRAS ID

  98985

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca Pharmaceuticals

• Eudract number

  2011-005986-20

• Research summary

  AZD8848 is a drug that may be useful in the treatment of asthma. People with asthma have sensitive airways which become irritated in some situations (e.g. in reaction to dust or pollen). The airways become narrow and sometimes produce more mucus than usual. This makes it difficult to breathe. AZD8848 is a drug which works on a protein called toll-like receptor (TLR) 7 in the lungs and acts to reduce the inflammatory response to environmental agents such as tree and grass pollen , often seen in asthmatics . As such it has the potential to induce long-term disease control in asthma. It has been tested in the nose of people with allergic rhinitis (hayfever-like symptoms) but it has never been given to humans via oral inhalation. This will be the first time it will be given to human volunteers this way. The purpose of this research study is to evaluate safety and tolerability of AZD8848 when given by oral inhalation and how much AZD8848 enters the blood circulation by collecting blood and urine samples during the study. We are also investigating what it is broken down into and how much of the drug is cleared from the body. This will be done by analysis of blood and urine samples. The total volume of blood to be taken for the entire duration of the study will be no greater than 450 ml, less than the equivalent of 1 unit given in a routine blood donation session. The study will take place at Quintiles Drug Research Unit at Guy??s Hospital, Quintiles Ltd. The study will involve up to 8 groups of 6 volunteers. Volunteers will receive a single dose of AZD8848 or placebo (dummy). There will be 5 visits to the unit including a residential visit lasting 3 nights/4days.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/0275

• Date of REC Opinion

  25 Apr 2012

• REC opinion

  Further Information Favourable Opinion