NOV012 Bacteriophage First in human study

• Research type

  Research Study

• Full title

  A study to investigate the safety, tolerability and preliminary efficacy of an intranasal gel containing a bacteriophage cocktail (NOV012) in healthy subjects, including subjects who are known SA carriers

• IRAS ID

  91029

• Contact name

  Joseph Chiesa

• Sponsor organisation

  Novolytics Limited

• Eudract number

  2011-004646-17

• Research summary

  The proposed study is to investigate the safety, tolerability and efficacy of a gel containing two types of viruses which kill bacteria (NOV012) in healthy subjects including subjects who are known Staphylococcus aureus carriers. The study will be conducted in three parts: A, B and C. All subjects in Part A and C will be resident from the day before dosing to 24 hours post-dose and will return for a post study visit approximately 5 to 7 days post-dose. All subjects in Part B will reside at the Unit from the day before dosing to Day 6 (24 h after the final dose) and would return for assessments on Days 8, 15, 22 and 30 post dose.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0171

• Date of REC Opinion

  22 Nov 2011

• REC opinion

  Further Information Favourable Opinion