Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
NCT ID: NCT05425446
Last Updated: 2025-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
56 participants
INTERVENTIONAL
2022-09-19
2025-01-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SAD Cohort 1
All randomized patients will receive one dose of either DONQ52 Dose A or placebo
DONQ52
Subcutaneous (SC) injection
Placebo
Subcutaneous (SC) injection
SAD Cohort 2
All randomized patients will receive one dose of either DONQ52 Dose B or placebo
DONQ52
Subcutaneous (SC) injection
Placebo
Subcutaneous (SC) injection
SAD Cohort 3
All randomized patients will receive one dose of either DONQ52 Dose C or placebo
DONQ52
Subcutaneous (SC) injection
Placebo
Subcutaneous (SC) injection
SAD Cohort 4
All randomized patients will receive one dose of either DONQ52 Dose D or placebo
DONQ52
Subcutaneous (SC) injection
Placebo
Subcutaneous (SC) injection
MAD Cohort 1
All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo
DONQ52
Subcutaneous (SC) injection
Placebo
Subcutaneous (SC) injection
MAD Cohort 2
All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo
DONQ52
Subcutaneous (SC) injection
Placebo
Subcutaneous (SC) injection
MAD Cohort 3
All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo
DONQ52
Subcutaneous (SC) injection
Placebo
Subcutaneous (SC) injection
Interventions
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DONQ52
Subcutaneous (SC) injection
Placebo
Subcutaneous (SC) injection
Eligibility Criteria
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Inclusion Criteria
* Be on a GFD for at least 12 months
* HLA-DQ2.5 genotype
* Experienced at most mild symptoms of celiac disease
Exclusion Criteria
* Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)
18 Years
70 Years
ALL
No
Sponsors
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Chugai Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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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
Countries
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Other Identifiers
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DQB101US
Identifier Type: -
Identifier Source: org_study_id
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