104
Participants
Start Date
September 14, 2018
Primary Completion Date
August 11, 2019
Study Completion Date
September 13, 2019
EHP-101 Liquid single dose
One single oral administration with EHP-101 liquid formulation. The doses will be ascending per cohort from 0.91 mg to 200 mg. The initially planned once daily dose regimen may be modified by the Safety Review Committee based on emerging PK data, eg, assigned dose levels may be divided into 2 doses administered 12 hours apart (twice a day).
EHP-101 Liquid multiple doses
One single daily administration with EHP-101 liquid formulation during 7 consecutive days. The doses will be ascending per cohort. Each ascending level will not exceed the tested dose levels in the single dose part of the study. The initially planned once daily dose regimen may be modified by the Safety Review Committee based on emerging PK data, eg, assigned dose levels may be divided into 2 doses administered 12 hours apart (twice a day)
Matching placebo
Oral liquid administration daily
Nucleus Network, Melbourne
Lead Sponsor
Emerald Health Pharmaceuticals
INDUSTRY