To Evaluate the Safety and Tolerability, Pharmacokinetics, Food-effect and Pharmacodynamics of EHP-101 in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

104

Participants

Timeline

Start Date

September 14, 2018

Primary Completion Date

August 11, 2019

Study Completion Date

September 13, 2019

Conditions
Healthy
Interventions
DRUG

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).

DRUG

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)

DRUG

Matching placebo

Oral liquid administration daily

Trial Locations (1)

3004

Nucleus Network, Melbourne

Sponsors
All Listed Sponsors
lead

Emerald Health Pharmaceuticals

INDUSTRY