To assess safety/tolerability and PK/PD AZD8848 in MAD.
Research type
Research Study
Full title
A Phase 1, Single Centre, Double-blind, Randomised, Placebo-controlled, Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics after Administration of Multiple Ascending (MAD)Once Weekly Inhaled Doses of AZD8848 in Healthy Subjects.
IRAS ID
129027
Contact name
Leonard Siew
Contact email
Sponsor organisation
AstraZeneca Pharmaceuticals
Eudract number
2012-002809-21
ISRCTN Number
n/a
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) and has been given to healthy volunteers via oral inhalation in one study.
The purpose of this research study is to evaluate the safety & tolerability of multiple doses of AZD8848 when given by oral inhalation and see 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 500 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 3 groups of 8 volunteers. Volunteers will receive a 4 doses once-weekly of AZD8848 or placebo (dummy).
There will be 11 visits to the unit including 4 residential visits lasting 2 nights/3 days. In addition, women of childbearing potential will have 2 telephone contact 'visits'; other volunteers, 1.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
13/LO/0988
Date of REC Opinion
11 Oct 2013
REC opinion
Further Information Favourable Opinion