Clinical Trial: A Safety and PK Study of EC-18 in Healthy Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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 Subjec
Brief Summary: The purpose of this study is to determine if EC-18 is safe and tolerable in healthy subjects.
Detailed Summary: 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.
Sponsor: Enzychem Lifesciences Corporation
Current Primary Outcome: The primary endpoint of the study will be the number and severity of treatment emergent adverse events (TEAEs) following single doses of EC-18 and placebo. [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To determine the composite pharmacokinetic (PK) parameters of EC-18 following sngle oral doses. AUC0-t, AUC0-24, Cmax, Tmax, 48-hour time period. [ Time Frame: Predose [0], 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 hours post dose ]
Original Secondary Outcome: Same as current
Information By: Enzychem Lifesciences Corporation
Dates:
Date Received: June 29, 2015
Date Started: July 2015
Date Completion:
Last Updated: January 7, 2016
Last Verified: January 2016