drugset / Trial / NCT01434693
Safety and Tolerability of Single Doses Oral CNDO 201 Trichuris Suis Ova in Patients With Crohn's Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |