A Study to Assess Safety, Tolerability and Pharmacokinetics of of AZD6553 in Healthy Volunteers and Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Study to Assess Safety, Tolerability and Pharmacokinetics of of AZD6553 in Healthy Volunteers and Patients With Chronic Obstructive Pulmonary Disease (COPD)
AZD6553 is a new drug being developed as a possible treatment for patients with chronic
 obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair
 of two commonly co-existing diseases of the lungs in which the airways become inflamed and
 the small airsacs of the lungs become damaged. This leads to a limitation of the flow of air
 to and from the lungs causing shortness of breath. In contrast to asthma, the limitation of
 airflow is poorly reversible and usually gets progressively worse over time. There is an
 urgent medical need for therapies that could slow disease progression by targeting the
 underlying mechanisms associated with the changes in the lungs in patients with COPD. AZD6553
 acts by reducing the activity of a protease found to be involved in the disease process in
 COPD. AZD6553 is being developed as a novel oral treatment to control the symptoms and
 exacerbations of COPD, and reduce the progression and severity of the disease. The purpose of
 this research study is to determine how safe and well-tolerated AZD6553 is and how much
 AZD6553 enters blood circulation by collecting blood and urine samples during the study. We
 are also investigating what AZD6553 is broken down into, when given orally, how much of the
 drug is cleared from the body via the kidneys, and the effect of taking the drug after food.
 This will all be done by analysis of blood and urine samples taken at various point during
 the study.
Inclusion Criteria:

 -  Parts A and B only; Body mass index (BMI) between 18 and 30 kg/m2.

 -  Parts A and B only; Normal physical examination, laboratory values, and vital signs
 (blood pressure and pulse) unless the investigator considers an abnormality to be
 clinically irrelevant.

 -  Part C only; clinical diagnosis of COPD for at least one year and Post-bronchodilator
 FEV1 30 - 80% predicted, FEV1/FVC ratio < 70%

 Exclusion Criteria:

 -  Participation in any clinical study with an investigational drug or new formulation of
 a marketed drug in the 3 months prior to Visit 2, or participation in a method
 development study one month prior to Visit 1

 -  Part C only: An acute exacerbation or acute respiratory infection (upper or lower) in
 the 4 weeks prior to Visit 1 or Visit 2.

 -  Part C only: Concomitant diagnosis of significant pulmonary disease other than COPD,
 including symptomatic asthma, cystic fibrosis and allergic bronchopulmonary
 aspergillosis