drugset / Trial / NCT01725594

A Single and Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of CAT-2003

NCT01725594 ↗

Phase 1 Completed 99 enrolled Catabasis Pharmaceuticals
RandomizedParallel-groupQuadruple-blind

Summary

This is a two-part Phase 1 placebo-controlled, double-blind, randomized single and multiple ascending dose study. In Part A, CAT-2003 is administered as a single dose; at two doses (1000 and 2000 mg), subjects will return for a second dose of CAT-2003 or placebo after a high fat meal. In Part B, CAT-2003 is administered for 14 consecutive days.

Timeline

Start
2012-11
Primary completion
2013-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject CAT-2003 Unknown 1000 mg —
Subject CAT-2003 Unknown 2000 mg —

Indications