Phase 1 study to investigate safety, tolerability, and PK of BisEDT

• Research type

  Research Study

• Full title

  BisEDT - A Phase I, Double-Blind, Placebo Controlled, Single Topical Dose, Safety, Tolerability and Pharmacokinetic Study in Healthy Male Subjects

• IRAS ID

  80414

• Sponsor organisation

  Microbion Corporation

• Eudract number

  2011-001677-56

• Research summary

  Microbion Corporation is developing a novel class of antimicrobial agents (bismuth-thiols) that shows potent, broad-spectrum antibacterial activity. It is hoped that BisEDT will be able to treat patients suffering from wounds that are susceptible to infection. Bis EDT (Bismuth Thiols) has demonstrated the ability to inhibit Gram-positive microbes (including MRSA), and to kill Gram-negative microbes in pre-clinical studies conducted. This is an ascending single topical dose study. The study will be double blind, placebo controlled and the group will be dosed in a fixed sequence. 40 subjects will be studied in 5 groups (Groups A to E), each group consisting of 8 subjects.Each subject will participate in 1 treatment period only, residing at the CRU from Day ??1 (the day before dosing) to Day 2 (24 hours postdose), subjects will then return for a short outpatient visit on Day 3 (48 hours post dose). All subjects will return for a poststudy visit 5 to 7 days after their dose. In each of Groups A to E, 6 subjects will receive BisEDT and 2 will receive placebo at the test site. In addition all subjects will have a control site where only the placebo suspension is applied. All doses will be applied to the skin on the morning of Day 1 and will remain in place for approximately 6 hours. Each subject will receive only a single dose of BisEDT or placebo at the test site during the study.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0078

• Date of REC Opinion

  25 May 2011

• REC opinion

  Favourable Opinion