First in human study of single ascending inhaled doses of AZD7624

• Research type

  Research Study

• Full title

  A Double-blind Placebo-controlled, Randomised, Single centre, First Time in Man Study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD7624 in Healthy Subjects

• IRAS ID

  118461

• Contact name

  Darren Wilbraham

• Sponsor organisation

  AstraZeneca R&D

• Eudract number

  2012-004604-35

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  AZD7624 is a new drug being developed by AstraZeneca (the Sponsor, a pharmaceutical company) 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. COPD is a major global health problem which is increasing throughout the world and a major cause of death. However, current therapies fail to prevent disease progression or mortality. There is a large unmet need of more effective anti-inflammatory treatments. AZD7624 is an anti-inflammatory drug 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) various increasing single inhaled doses of AZD7624 in healthy volunteers. Approximately 56 healthy volunteers will participate initially in 5 groups of 8 volunteers each. Additional 2 groups might be enrolled depending upon the results of previous groups. The study will involve 3 visits including a screening visit, a residential stay of 4 days/3 nights and a follow up visit. The study duration will be approximately between 3 to 8 weeks.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  12/LO/1866

• Date of REC Opinion

  21 Jan 2013

• REC opinion

  Further Information Favourable Opinion