NCT01434693

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

A Sequential Dose-Escalation, Double-Blind, Placebo-Controlled, Phase I Study to Evaluate the Safety and Tolerability of Single Doses of 3 Different Doses of Oral CNDO 201 Trichuris Suis Ova Suspension (Tso) in Patients With Crohn's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Coronado Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
BIOLOGICAL	Trichuris suis ova	single dose
OTHER	Placebo

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-04-01
• Completion: 2012-09-01
• First posted: 2011-09-15
• Last updated: 2013-05-20
• Results posted: 2013-05-20

Locations

7 sites across 1 country: United States