Safety, Tolerability, and Pharmacokinetics of Oral EC5026 in Healthy Subjects

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

December 9, 2019

Primary Completion Date

July 7, 2020

Study Completion Date

July 7, 2020

Conditions
Healthy Adults
Interventions
DRUG

EC5026 oral capsule

"5 sequential cohorts of 8 subjects randomly assigned to receive single ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort).~Oral doses of EC5026 tested in each cohort: 0.5 mg (Cohort 1), 2 mg (Cohort 2), 8 mg (Cohort 3), 16 mg (Cohort 4), and 24 mg (Cohort 5).~A blinded sentinel group of 2 subjects (1 active and 1 placebo) will be dosed at least 2 days before the remaining 6 subjects (5 active and 1 placebo) will receive blinded doses of active study drug or placebo."

OTHER

Placebo oral capsule

5 sequential cohorts of 8 subjects randomly assigned to receive single ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort)

Trial Locations (1)

78744

PPD Phase I Clinic, Austin

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

EicOsis Human Health Inc.

INDUSTRY

NCT04228302 - Safety, Tolerability, and Pharmacokinetics of Oral EC5026 in Healthy Subjects | Biotech Hunter | Biotech Hunter