To investigate the safety and pharmacokinetics of V-073

• Research type

  Research Study

• Full title

  A randomized, double-blind, parallel group, placebo-controlled study of the safety, tolerability and pharmacokinetics of single and multiple oral doses of V-073 in healthy adult volunteers

• IRAS ID

  68144

• Contact name

  Darren Wilbraham

• Sponsor organisation

  ViroDefence Inc

• Eudract number

  2010-023817-69

• ISRCTN Number

  xx

• Research summary

  V-073 is a new drug being developed for the treatment of poliovirus infections. It is being tested for the first time in humans. V-073 is anticipated to act to stop poliovirus excretion in individuals infected with or exposed to poliovirus, providing benefit to both the treated individuals, by reducing their risk for poliomyelitis, and the community, by lowering the number of infections during polio outbreaks. Poliomyelitis is a disease caused by the poliovirus that may affect the central nervous system causing muscle weakness, paralysis, and death. The purpose of this study is to examine the safety, tolerability and the way the body handles (absorbs, distributes, breaks down and excretes) various increasing single and multiple doses of V-073 in healthy volunteers.The study will take place at Quintiles Drug Research Unit at Guy??s Hospital, Quintiles Ltd. The study involves several visits to the research unit, with a pre-study screening visit and a post-study follow-up visit. The study is expected to involve a total of approximately 100 healthy volunteers.The information gained in this study will help the sponsor of this study to determine the next steps in the development of V-073.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  10/H0802/84

• Date of REC Opinion

  14 Dec 2010

• REC opinion

  Further Information Favourable Opinion