Phase 1 Dose-Escalation of TP2758, Safety, Tolerability

• Research type

  Research Study

• Full title

  A Phase 1, Randomized, Placebo-Controlled, Single-Blind Dose-Escalation Study to Assess the Safety, Tolerablity and Pharmacokinetics of Single and Multiple Dose Administrations of TP-2758 in Normal Healthy Volunteers

• IRAS ID

  89931

• Contact name

  Pui Man (known as Paul) Leung

• Sponsor organisation

  Tetraphase Pharmaceuticals, Inc.

• Eudract number

  2011-004643-41

• ISRCTN Number

  1

• Research summary

  There is increasing incidence of multidrug resistance among gram-positive and gram-negative pathogens. New antibiotics effective against these multi-drug resistant pathogens are required.Following oral administration in monkeys, TP-2758 has a long half-life and an oral bioavailability of 30.4%. TP-2758 is being developed as therapy for serious bacterial infections.

• REC name

  Wales REC 2

• REC reference

  11/WA/0287

• Date of REC Opinion

  14 Oct 2011

• REC opinion

  Favourable Opinion