Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
- Registration Number
- NCT05425446
- Lead Sponsor
- Chugai Pharmaceutical
- 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 well-controlled celiac disease patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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
- Refractory celiac disease
- Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MAD Cohort 2 Placebo All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo SAD Cohort 1 Placebo All randomized patients will receive one dose of either DONQ52 Dose A or placebo SAD Cohort 2 Placebo All randomized patients will receive one dose of either DONQ52 Dose B or placebo MAD Cohort 3 Placebo All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo SAD Cohort 3 Placebo All randomized patients will receive one dose of either DONQ52 Dose C or placebo SAD Cohort 4 Placebo All randomized patients will receive one dose of either DONQ52 Dose D or placebo MAD Cohort 1 Placebo All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo SAD Cohort 1 DONQ52 All randomized patients will receive one dose of either DONQ52 Dose A or placebo SAD Cohort 2 DONQ52 All randomized patients will receive one dose of either DONQ52 Dose B or placebo SAD Cohort 4 DONQ52 All randomized patients will receive one dose of either DONQ52 Dose D or placebo MAD Cohort 1 DONQ52 All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo MAD Cohort 2 DONQ52 All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo MAD Cohort 3 DONQ52 All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo SAD Cohort 3 DONQ52 All randomized patients will receive one dose of either DONQ52 Dose C or placebo
- Primary Outcome Measures
Name Time Method Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher Up to 246 days Incidence and severity of TEAEs and its relationship to the study drugs
Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate) Up to 246 days Abnormality in Electrocardiograms (ECGs)
Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis) Up to 246 days Incidence of laboratory abnormalities, based on clinical laboratory tests
Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation) Up to 246 days Abnormality in vital signs
- Secondary Outcome Measures
Name Time Method Pharmacokinetics; Serum DONQ52 concentration Up to 246 days Serum DONQ52 concentrations over time
Pharmacokinetics; Area under the serum concentration time curve [AUC] Up to 246 days AUC of DONQ52
Pharmacokinetics; Maximum serum concentration [Cmax] Up to 246 days Cmax of DONQ52
Pharmacokinetics; Time to maximum serum concentration [Tmax] Up to 246 days Tmax of DONQ52
Pharmacokinetics; Half life [T1/2] Up to 246 days T1/2 of DONQ52
Immunogenicity Up to 246 days Prevalence and incidence of anti-drug antibodies (ADAs) to DONQ52
Trial Locations
- Locations (21)
Pinnacle Research Group
🇺🇸Anniston, Alabama, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Digestive Specialists Inc
🇺🇸Dayton, Ohio, United States
Long Island Gastrointestinal Research Group
🇺🇸Great Neck, New York, United States
Clinical Site Partners
🇺🇸Leesburg, Florida, United States
Campbelltown Hospital
🇦🇺Campbelltown, New South Wales, Australia
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Velocity Clinical Research, Anderson
🇺🇸Anderson, South Carolina, United States
University of Sunshine Coast Clinical Trials Centre - Morayfield
🇦🇺Morayfield, Queensland, Australia
Lucas Research - Diabetes & Endocrinology Consultants, PC
🇺🇸Morehead City, North Carolina, United States
Velocity Clinical Research - Boise
🇺🇸Meridian, Idaho, United States
Clinical Site Partners - Orlando
🇺🇸Winter Park, Florida, United States
Aventiv Research, Inc.
🇺🇸Columbus, Ohio, United States
Mountain View Clinical Research
🇺🇸Denver, Colorado, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
Linear Clinical Research
🇦🇺Nedlands, Western Australia, Australia
Alliance for Multispecialty Research
🇺🇸Knoxville, Tennessee, United States
Tandem Clinical Research
🇺🇸Marrero, Louisiana, United States
Care Access Research
🇺🇸Ogden, Utah, United States
Digestive Research of Central Texas
🇺🇸Waco, Texas, United States