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The purpose of this research study is to look at how effective and safe AT-1001 is when it is given along with a gluten challenge to subjects who are diagnosed with Celiac Disease, are in remission and are on a gluten-free diet. AT-1001 block intestinal permeability and the genesis of autoimmune disease, either as a result of reduction of antigen presentation to immune tissue, or through some unknown inhibitory, direct effect on immune cells. Four clinical trials have been completed using the drug AT-1001 so far. Headache was the most common side effect. All side effects were mild and no serious side effects were seen. One subject reported a mild rash that lasted one day and went away without treatment. Another subject reported a rash caused by the ECG electrode. Other common side effects were nausea, flatulence, and diarrhea; however, these symptoms may be related to the gluten challenge. All side effects were mild or moderate and no serious side effects were. Expected gastrointestinal side effects resulting from gluten ingestion in celiac patients include dermatitis herpetiformis, aphthous ulcers, abdominal discomfort, dyspepsia, nausea, diarrhea, vomiting, flatulence or constipation

The study population will consist of adults between the ages of 18 and 65, diagnose with celiac disease by duodenal/jejunal biopsy at least 6 months prior to entrance into the study. Subject has anti-tissue tranglutaminase (anti-tTG) les than 30 EU as measured by serology; must be on a gluten-free diet for at least 6 months

Study Summary:

Detailed Study Description:

Study Design: Blinded
Phase of Study: Phase II
Study Type: Observational
Condition or Study Focus: Celiac Disease subjects in Remission
Intervention Type: AT1001
Intervention Name: AT1001
Gender: Male and Female
Age group: Observational
Sponsor: Alba Therapeutics Corporation