Status:
COMPLETED
Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Celiac Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- Refractory celiac disease
- Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)
Key Trial Info
Start Date :
September 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05425446
Start Date
September 19 2022
End Date
January 17 2025
Last Update
January 31 2025
Active Locations (21)
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1
Pinnacle Research Group
Anniston, Alabama, United States, 36207
2
Mountain View Clinical Research
Denver, Colorado, United States, 80209
3
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
4
Clinical Site Partners
Leesburg, Florida, United States, 34748