Effects of Gluten Digestion With ALV003 (0801)

Inclusion Criteria:

• Age 18-75 years
• Well controlled Celiac Disease without flare in symptoms for the past 8 weeks
• History of biopsy proven Celiac Disease
• Able and willing to complete a symptom diary for 3 days prior and through 3 days post gluten challenge
• Been on a gluten free diet for 8 weeks prior to study entry
• Have normal celiac serology (anti- tTG level of <20 units/mL)

Exclusion Criteria:

• Uncontrolled complications of celiac disease which in the opinion of the Investigator would impact their immune response, or pose an increased risk to the subject. (example: like type 1 diabetes or other autoimmune disease)
• Pregnant or breast feeding women, subjects of childbearing potential to use two methods of contraception
• Concomitant medications such as over the counter digestive enzymes, immunosuppressive therapies, anticoagulants, NSAIDs. Chronic medications for well-controlled chronic conditions are allowed.
• Clinically significant abnormal lab values, as determined by the PI:
• Untreated or active peptic ulcer disease, esophagitis, motility disorders or any gastrointestinal diseases.
• Positive pregnancy test within 7 days prior to study drug administration
• Known allergy or hypersensitivity to E.coli or E.coli derived proteins