Safety and Tolerability Study of AT1001 in Celiac Disease Subjects
There are no therapeutic products on the market for celiac disease today. Current treatment is limited to gluten free foods and a gluten-free diet.
The main purpose of this study is to test how safe, efficacious and tolerable the study drug AT1001 is in subjects with diagnosed celiac disease.
A second purpose is to study how your body responds to the drug when you ingest gluten. This response is determined by testing your urine, and by capturing your daily and weekly gastrointestinal symptoms associated with celiac disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Multicenter Study to Determine the Safety, Tolerance, and Efficacy of AT-1001 in Celiac Disease Subjects During Gluten Challenge.|
- To demonstrate the safety and tolerability of multiple, oral doses of AT-1001 in celiac disease subjects that maintain a gluten-free diet.
- To evaluate the efficacy of multiple dose levels of AT-1001 in preventing intestinal permeability changes induced by gluten challenge
- to evaluate the effects of multiple dose levels of AT-1001 in preventing the induction of celiac disease signs and symptoms resulting from gluten challenge.
|Study Start Date:||August 2006|
|Study Completion Date:||March 2007|
|United States, Arizona|
|Scottsdale, Arizona, United States, 85259|
|United States, California|
|San Diego, California, United States, 92123|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02215|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, New Jersey|
|Morristown, New Jersey, United States, 07960|
|United States, North Dakota|
|Bismarck, North Dakota, United States, 58501|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|Pittsburgh, Pennsylvania, United States, 15241|
|United States, Virginia|
|Richmond, Virginia, United States, 23298|