To investigate the effect of POL7080 on healthy male subjects

• Research type

  Research Study

• Full title

  A phase I single-centre, double-blind, randomised, placebo-controlled clinical trial to investigate the safety, tolerability and pharmacokinetics of POL7080 administered as single and multiple intravenous (infusion) ascending doses to healthy male subjects

• IRAS ID

  50476

• Contact name

  Darren Wilbraham

• Sponsor organisation

  Polyphor Ltd

• Eudract number

  2010-018616-32

• Research summary

  The drug being tested in this trial is POL7080. It is being developed as a possible treatment for serious bacterial infections caused by Pseudomonas aeruginosa. This will be the first time that POL7080 is given to humans. The purpose of this research is to investigate the safety and tolerability of POL7080, and how the body handles single and multiple intravenous ascending doses of POL7080. Up to 60 healthy young male volunteers will be enrolled in Part A (single ascending dose investigation) of the study, and up to 40 healthy young male volunteers will be enrolled in Part B (repeated dose investigation). The study will take place at Quintiles Drug Research Unit, Quintiles Ltd. The information gained in this study will help the sponsor to determine whether POL7080 is suitable for further research studies in humans.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  10/H0804/19

• Date of REC Opinion

  19 May 2010

• REC opinion

  Further Information Favourable Opinion