To investigate the safety, tolerability, PK & PD of subcutaneous PA401

• Research type

  Research Study

• Full title

  A Phase I, First in Human, double-blind randomised placebo-controlled study to investigate the safety, tolerability, immunogenicity and pharmacokinetics of single and multiple doses of subcutaneous PA401, and to investigate the effects of a single dose of PA401 on sputum neutrophils following inhaled lipopolysaccharide challenge, in healthy subjects.

• IRAS ID

  103531

• Contact name

  Darren Wilbraham

• Sponsor organisation

  ProtAffin Biotechnologie AG

• Eudract number

  2012-001189-14

• Research summary

  The drug being tested in this study, PA401, is being developed for the possible treatment of inflammatory lung conditions such as 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 air sacs of the lungs become damaged. This leads to a limitation of the flow of air to and from the lungs causing shortness of breath, which can lead to exacerbations requiring hospital treatment. This will be the first time the drug will be administered to humans. PA401 is a modified form of the human IL-8 chemokine. Chemokines are a family of small proteins secreted by cells - the smallest units of life. IL-8 is one of the major proteins that take part in an inflammatory response ??a response of the body to a harmful stimulus. The purpose of this study is to examine the safety, tolerability, immunogenicity (the ability of the study drug to provoke an immune response in the body) and the way the body handles (absorbs, distributes, breaks down and excretes) various increasing single and multiple subcutaneous doses (injection under the skin) of PA401 in healthy subjects. This study will also look at the effect of PA401 on inflammation in the lungs following an inhaled lipopolysaccharide (LPS) challenge (LPS is a bacterial cell wall fragment) and sputum induction (a procedure performed to help to cough up sputum, or phlegm) after a single subcutaneous dose of two dose levels.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  12/LO/0643

• Date of REC Opinion

  25 May 2012

• REC opinion

  Further Information Favourable Opinion