Looks like phase 1 they previously tested doses in humans up to 18mg/kg/week which would work out equivalent to the 400mg daily dose 3 times for a week.
I also read they had previously done animal tox studies prior to phase 1 as you would expect and obviously was ok to proceed to test in humans.
Adds to the mystery of how Teva saw anything negative from their tox study...
ann: atl 1102 trial commencement, page-17
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