NCT02496143

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

A Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Administration of EC-18 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Enzychem Lifesciences Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects.

Detailed description

This will be a randomized, double-blind, placebo-controlled study of the safety, tolerability, PK, and pharmacodynamics of single ascending doses of EC-18 or placebo. If no dose limiting toxicity (DLT) is observed in Cohort One, the dose of EC-18 will be increased to in Cohorts Two, Three, and Four, respectively. Dose escalation to each successive cohort of subjects will not occur until a review of the safety and tolerability data from the previous cohort is completed and the Investigator, Sponsor, and study Medical Monitor together confirm the safety and tolerability of EC-18 given at that dose level.

Conditions

• Chemotherapy-induced Neutropenia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2015-07-14
• Last updated: 2016-01-11

Locations

1 site across 1 country: United States