Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
Celiac Disease
About this trial
This is an interventional treatment trial for Celiac Disease
Eligibility 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:
- Refractory celiac disease
- Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)
Sites / Locations
- Pinnacle Research GroupRecruiting
- Diablo Clinical ResearchRecruiting
- Jacksonville Center for Clinical ResearchRecruiting
- Clinical Site Partners - OrlandoRecruiting
- Velocity Clinical Research - BoiseRecruiting
- Tandem Clinical ResearchRecruiting
- Lucas Research - Diabetes & Endocrinology Consultants, PCRecruiting
- North Carolina Clinical ResearchRecruiting
- Aventiv Research, Inc.Recruiting
- Velocity Clinical Research, AndersonRecruiting
- Alliance for Multispecialty ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
SAD Cohort 1
SAD Cohort 2
SAD Cohort 3
SAD Cohort 4
MAD Cohort 1
MAD Cohort 2
MAD Cohort 3
All randomized patients will receive one dose of either DONQ52 Dose A or placebo
All randomized patients will receive one dose of either DONQ52 Dose B or placebo
All randomized patients will receive one dose of either DONQ52 Dose C or placebo
All randomized patients will receive one dose of either DONQ52 Dose D or placebo
All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo
All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo
All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo