4 part safety study of PUR118 in healthy volunteers and COPD Patients

• Research type

  Research Study

• Full title

  A Four-Part Study to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of PUR118 and Placebo in Normal Healthy Volunteers and Subjects with COPD.

• IRAS ID

  67652

• Contact name

  Stuart J Mair

• Sponsor organisation

  Pulmatrix, Inc

• Eudract number

  2010-023295-40

• Research summary

  The drug being tested is PUR118, which will be administered by a dry powder inhaler to healthy volunteers and COPD patients in a stepwise progression. COPD is a disease in which the airways to the lungs become inflamed and narrowed and the lungs themselves become damaged and less able to transfer oxygen into the blood stream. This results in COPD sufferers becoming short of breath. Unlike other diseases such as asthma where inhalers can be used to reduce the narrowing of the airways, the narrowing in COPD is difficult to reverse. COPD is most often caused by inhalation of harmful gases and particles such as those contained in cigarette smoke, although other harmful substances and some inherited diseases can also cause the disease. It is estimated that COPD affects up to 10% of adults over 40 years of age worldwide and in the UK the majority of cases are associated with cigarette smoking. The study has been split into 4 parts to enable different doses to be evaluated in both healthy volunteers and COPD patients. The primary purpose of this study is to: Evaluate single dose safety and tolerability of PUR118 (low, mid, and high dose) and placebo in healthy adult volunteers (Part 1).Evaluate multiple-dose safety and tolerability of PUR118 (low, mid, and high dose) and placebo in healthy adult volunteers (Part 2).Evaluate the multiple dose safety and tolerability of PUR118 in subjects with mild, stable COPD (Part 3).Evaluate the single dose safety and tolerability of PUR118 in patients with mild, stable COPD and evaluate the impact of single dose administrations of PUR118 on mucociliary clearance in comparison with no treatment (Part 4). A secondary, exploratory objective of the study is to evaluate the impact of 3 dose administrations of PUR118 on biomarkers of COPD (Part 3).

• REC name

  HSC REC A

• REC reference

  10/NIR01/68

• Date of REC Opinion

  1 Dec 2010

• REC opinion

  Favourable Opinion