drugset / Trial / NCT01434693

Safety and Tolerability of Single Doses Oral CNDO 201 Trichuris Suis Ova in Patients With Crohn's Disease

NCT01434693 ↗

Phase 1 Completed 36 enrolled Coronado Biosciences, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a sequential dose-escalation (with up to 3 dose levels of TSO, ie, 500, 2500, and 7500 TSO), randomized (within each of 3 periods, with a ratio of 3:1 for TSO to placebo), double-blind, placebo-controlled study to evaluate the safety of a single dose of oral CNDO-201 Trichuris suis ova suspension, as compared to placebo, in patients with Crohn's Disease.

Timeline

Start
2011-11
Primary completion
2012-04
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Trichuris suis ova Other / unclassified 500 unknown Oral
Subject Trichuris suis ova Other / unclassified 2500 unknown Oral
Subject Trichuris suis ova Other / unclassified 7500 unknown Oral

Indications