Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- Refractory celiac disease
- Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Celiac Disease
Age (in years)
18 - 70
Phase
Phase 1
Participants needed
56
Est. Completion Date
May 31, 2024
Treatment type
Interventional
Sponsor
Chugai Pharmaceutical
ClinicalTrials.gov identifier
NCT05425446
Study number
DQB101US
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