A Study Of HT61 in healthy volunteers.

• Research type

  Research Study

• Full title

  A randomised, blinded, multiple, ascending dose study of HT61 formulations applied to the anterior nares of healthy volunteers.

• IRAS ID

  78593

• Contact name

  Pui Man Leung

• Sponsor organisation

  Helperby Therapeutics Limited

• Eudract number

  2011-001392-39

• ISRCTN Number

  1

• Research summary

  The drug that is being tested is HT61, a new antibiotic drug which is being developed for the treatment of MRSA (methicillin-resistant Staphylococcus aureus). Carriage of MRSA does not harm most people, but the bacterium can be passed on to other people who may be at risk (e.g. if they have had surgery) and then can cause a clinical infection. Such infections are difficult to treat because the MRSA bacteria is often resistant to a wide range of antibiotics. Therefore, there is a need for a new topical (applied to the outside of the body) antibiotic which is effective at clearing MRSA from the person who is carrying it (i.e. killing the MRSA bacteria) Two previous studies have been carried out in 29 participants using the HT61 ointment. Overall, HT61 has been well tolerated with only a few instances of dryness or redness of the nose observed. The purpose of this study this study is to determine the safety and tolerability of the new HT61 ointment formulation when applied to the inside of the nostrils. The adverse events, vital signs, ECGs and clinical laboratory parameters will also be evaluated. We will also take blood samples to determine how much HT61 gets into the blood stream when taken at different concentrations.

• REC name

  Wales REC 2

• REC reference

  11/WA/0088

• Date of REC Opinion

  15 Apr 2011

• REC opinion

  Favourable Opinion