Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
Completed · Phase 1 · Has a placebo group
Conditions studied: Celiac Disease
In brief
This study is to characterize the safety and tolerability of an investigational drug called DONQ52 and consists of a single ascending dose part (Part A) and a multiple ascending dose part (Part B) in well-controlled celiac disease patients.
Key facts
- Study ID
- NCT05425446
- Run by
- Chugai Pharmaceutical
- People needed
- 56
- Starts
- 2022-09-19
- Expected to finish
- 2025-01-17
- Last updated by the study team
- 2025-01-31
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- History of medically diagnosed celiac disease based on biopsies and positive celiac serology.
- Be on a GFD for at least 12 months
- HLA-DQ2.5 genotype
- Experienced at most mild symptoms of celiac disease
You may not qualify if…
- Refractory celiac disease
- Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)
Where it is running
- Pinnacle Research Group — Anniston, Alabama, United States
- Mountain View Clinical Research — Denver, Colorado, United States
- Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
- Clinical Site Partners — Leesburg, Florida, United States
- Clinical Site Partners - Orlando — Winter Park, Florida, United States
- Velocity Clinical Research - Boise — Meridian, Idaho, United States
- Tandem Clinical Research — Marrero, Louisiana, United States
- Mayo Clinic - Rochester — Rochester, Minnesota, United States
- Long Island Gastrointestinal Research Group — Great Neck, New York, United States
- Columbia University Medical Center — New York, New York, United States
- Lucas Research - Diabetes & Endocrinology Consultants, PC — Morehead City, North Carolina, United States
- North Carolina Clinical Research — Raleigh, North Carolina, United States
- Aventiv Research, Inc. — Columbus, Ohio, United States
- Digestive Specialists Inc — Dayton, Ohio, United States
- Velocity Clinical Research, Anderson — Anderson, South Carolina, United States
- Alliance for Multispecialty Research — Knoxville, Tennessee, United States
- Digestive Research of Central Texas — Waco, Texas, United States
- Care Access Research — Ogden, Utah, United States
- Campbelltown Hospital — Campbelltown, New South Wales, Australia
- University of Sunshine Coast Clinical Trials Centre - Morayfield — Morayfield, Queensland, Australia
- Linear Clinical Research — Nedlands, Western Australia, Australia
Full record on ClinicalTrials.gov
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