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

ClinicalTrials.gov ID: NCT01434693

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT01434693
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Coronado Biosciences, Inc.; Industry
Enrollment: 36 participants

Conditions and interventions

Conditions

Crohn's Disease

Interventions

Trichuris suis ova Biological
Placebo Other

Biological · Other

Eligibility (public fields only)

Age range: 18 Years to 55 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 2011 (Type not available)
Primary completion: Apr 2012 (Actual)
Completion: Sep 2012 (Actual)
Last update posted: May 20, 2013

2011 – 2012

United States locations

U.S. sites: 7
U.S. states: 5
U.S. cities: 7

Facility	City	State	ZIP	Site status
Advanced Clinical Research Institute	Anaheim	California	92801	—
Borland-Groover Clinic	Jacksonville	Florida	32256	—
Shafran Gastroenterology Center	Winter Park	Florida	32789	—
Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan	48047	—
Midwest Center for Clinical Research	Lee's Summit	Missouri	64064	—
Center for Digestive & Liver Diseases, Inc	Mexico	Missouri	65265	—
Long Island Clinical Research Associates, LLP	Great Neck	New York	11021	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01434693, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 20, 2013 · Synced Nov 13, 2026