Double blind, placebo controlled, ascending single oral dose, sequential group study. Forty
subjects will complete the study in 5 cohorts (Groups A to E), each group consisting of 8
subjects. Each subject will be on study for approximately 6 weeks. Each subject will
participate in one treatment cohort only, residing at the Clinical Research Unit (CRU) from
Day -1 (the day before dosing) to Day 6 (120 hours post-dose). Each cohort will be dosed in a
leading edge design in which two subjects will receive study drug (1 active and 1 placebo) on
the first dosing day, and the last 6 will receive study drug (5 active and 1 placebo) on the
second dosing day.
All subjects will return for a post-study visit 8 to 10 days after the dose of study
medication.
Cohorts will be dosed at 2 weekly intervals. There will be a review of safety data, after the
first two subjects have been dosed and before dosing of the subsequent six subjects. There
will be a complete review of safety and pharmacokinetic data of each cohort prior to each
dose escalation.