A Safety and PK Study of EC-18 in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Chemotherapy-induced Neutropenia
Interventions
DRUG

EC-18

EC-18 will be supplied as 500 mg Softgel capsules. The study will include up to four sequential dose cohorts. Six subjects in each cohort will be randomized to receive EC-18: 500, 1000, 2000, or 4000 mg by oral administration of 1, 2, 4, and 8 EC-18 capsules, for Cohorts 1, 2, 3 or 4, respectively.

DRUG

Placebo

Placebo will be supplied as Softgel capsules. The study will include up to four sequential dose cohorts. Two subjects in each cohort will be randomized to placebo and will receive 1, 2, 4 or 8 placebo capsules for Cohorts 1, 2, 3 or 4, respectively.

Trial Locations (1)

27612

Carolina Phase I Clinical Research, Raleigh

All Listed Sponsors
lead

Enzychem Lifesciences Corporation

INDUSTRY