Safety and tolerability of inhaled and aerosolised OligoG CF-5/20

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled dose-escalation phase I study to evaluate the safety and tolerability of inhaled aerosolised OligoG CF-5/20 (G-block oligosaccharide derived from alginate polysaccharide) in healthy volunteers

• IRAS ID

  30260

• Contact name

  Salvatore Febbraro

• Eudract number

  2009-009330-33

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  This study aims to determine if an inhaled drug known as OligoG CF-5/20 can improve the symptoms of Cystic Fibrosis. Cystic Fibrosis is caused by a single faulty gene that controls the movement of salt in the body. Healthy volunteers aged between 18 and 65 years would be eligible for this study. The study will take place at the Phase 1 CRO Simbec Research Limited in Merthyr Tydfil and will last approximately 10 days from screening to post study follow up.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  09/H0304/70

• Date of REC Opinion

  15 Sep 2009

• REC opinion

  Further Information Favourable Opinion