Multiple Ascending Dose study of AZD7624
Research type
Research Study
Full title
A Phase I, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Inhaled Doses of AZD7624 in Healthy Subjects and Patients with Chronic Obstructive Pulmonary Disease
IRAS ID
124870
Contact name
Leonard Siew
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2013-000067-83
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
This will be the first time the study drug AZD7624 will be given to human volunteers in multiple once daily doses.
Currently it is being investigated in an ongoing first-in human single ascending dose (SAD) study in healthy volunteers (D2550C00001). This study (Study D2550C00002) is planned to start after the completion of dosing in the SAD study (Single Ascending Dose) with AZD7624.
AZD7624 is a new drug being developed as a possible treatment for patients with chronic obstructive pulmonary disease (COPD).
COPD is a chronic lung disease. People with COPD have trouble breathing in and out, known as airflow obstruction. Their lungs become inflamed due to irritation, usually from cigarette smoke.
AZD7624 is an anti-inflammatory drug under development that stops an enzyme called p38 mitogen-activated protein kinase (MAPK) from working. This enzyme plays an important role in the inflammation of lungs in COPD. Information from animal and laboratory tests suggests that AZD7624 might be helpful in the treatment of lung inflammation in COPD.
The purpose of this study is to examine the safety, tolerability and the way the body handles (absorbs, distributes, breaks down and excretes) multiple inhaled doses of AZD7624 in healthy volunteers when given by inhalation as once daily for 8 days.
After all healthy volunteers have completed the study AZD7624 will also be given by inhalation at one dose level once daily for 8 consecutive days in patients with COPD.The results from this study will form the basis for the doses of AZD7624 to be used in future clinical studies.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0177
Date of REC Opinion
6 Sep 2013
REC opinion
Further Information Favourable Opinion