Investigation of NVB302 in healthy male and female volunteers.

• Research type

  Research Study

• Full title

  A Phase I, Double-Blind, Randomised, Placebo-Controlled, Dose Escalating Study to Assess The Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of NVB302 Administered Orally to Healthy Volunteers.

• IRAS ID

  84618

• Sponsor organisation

  Novacta Biosystems Limited

• Eudract number

  2011-002703-14

• ISRCTN Number

  1

• Research summary

  The purpose of this study is to investigate a new type of antibiotic called NVB302. Antibiotics are used to treat bacterial infections. NVB302 is being developed to treat a type of infection called Clostridium Difficile (C .difficile). C. difficile infection has become a major cause of illness in patients with infections resulting from treatment in a hospital (or healthcare unit). The study will be conducted in 2 Parts:?½Part A: Single doses in up to 40 male and female volunteers?½Part B: Multiple doses in up to 32 male and female volunteersThis will be the first time that NVB302 will be tested in humans. This study will investigate the safety, tolerability, pharmacokinetics (how the body handles the drug) of NVB302.

• REC name

  Wales REC 2

• REC reference

  11/WA/0205

• Date of REC Opinion

  27 Jul 2011

• REC opinion

  Favourable Opinion