A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety and Tolerability in Patients With Celiac Disease
ImmusanT, Inc
84 participants
Aug 3, 2012
Interventional
Conditions
Summary
This a randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety and tolerability in patients with celiac disease who are on a gluten-free diet.
Eligibility
Inclusion Criteria1
- Diagnosis of Celiac Disease
Exclusion Criteria1
- Patient has not been prescribed and/or has not followed a GFD for at least 12 months.
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Interventions
The study will consist of a Screening Period, Treatment Period, and a Follow-up Period. Escalating dose cohorts will receive active (12 patients per cohort) or placebo given intradermally in a 2:1 ratio. Patients will receive the same dose for the whole Treatment period. During the Screening period medical history, physical examination, vital sign measurements, ECG, and laboratory assessment will be performed as safety assessments. These assessments will also be performed during the study. Adverse events and concomitant medications will be assessed from the Screening visit until the end of the study.
Locations(1)
View Full Details on ANZCTR
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ACTRN12612000355875