Celiac Disease Clinical Trial
Official title:
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate The Safety, Tolerability, Pharmacokinetics, and Biomarkers of DONQ52 in Celiac Disease Patients (LILY Study)
Verified date | May 2024 |
Source | Chugai Pharmaceutical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 56 |
Est. completion date | May 31, 2024 |
Est. primary completion date | May 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Australia | Campbelltown Hospital | Campbelltown | New South Wales |
Australia | University of Sunshine Coast Clinical Trials Centre - Morayfield | Morayfield | Queensland |
Australia | Linear Clinical Research | Nedlands | Western Australia |
United States | Velocity Clinical Research, Anderson | Anderson | South Carolina |
United States | Pinnacle Research Group | Anniston | Alabama |
United States | Aventiv Research, Inc. | Columbus | Ohio |
United States | Digestive Specialists Inc | Dayton | Ohio |
United States | Mountain View Clinical Research | Denver | Colorado |
United States | Long Island Gastrointestinal Research Group | Great Neck | New York |
United States | Jacksonville Center for Clinical Research | Jacksonville | Florida |
United States | Alliance for Multispecialty Research | Knoxville | Tennessee |
United States | Clinical Site Partners | Leesburg | Florida |
United States | Tandem Clinical Research | Marrero | Louisiana |
United States | Velocity Clinical Research - Boise | Meridian | Idaho |
United States | Lucas Research - Diabetes & Endocrinology Consultants, PC | Morehead City | North Carolina |
United States | Columbia University Medical Center | New York | New York |
United States | Care Access Research | Ogden | Utah |
United States | North Carolina Clinical Research | Raleigh | North Carolina |
United States | Mayo Clinic - Rochester | Rochester | Minnesota |
United States | Digestive Research of Central Texas | Waco | Texas |
United States | Clinical Site Partners - Orlando | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Chugai Pharmaceutical |
United States, Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher | Incidence and severity of TEAEs and its relationship to the study drugs | Up to 246 days | |
Primary | Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation) | Abnormality in vital signs | Up to 246 days | |
Primary | Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate) | Abnormality in Electrocardiograms (ECGs) | Up to 246 days | |
Primary | Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis) | Incidence of laboratory abnormalities, based on clinical laboratory tests | Up to 246 days | |
Secondary | Pharmacokinetics; Serum DONQ52 concentration | Serum DONQ52 concentrations over time | Up to 246 days | |
Secondary | Pharmacokinetics; Maximum serum concentration [Cmax] | Cmax of DONQ52 | Up to 246 days | |
Secondary | Pharmacokinetics; Time to maximum serum concentration [Tmax] | Tmax of DONQ52 | Up to 246 days | |
Secondary | Pharmacokinetics; Area under the serum concentration time curve [AUC] | AUC of DONQ52 | Up to 246 days | |
Secondary | Pharmacokinetics; Half life [T1/2] | T1/2 of DONQ52 | Up to 246 days | |
Secondary | Immunogenicity | Prevalence and incidence of anti-drug antibodies (ADAs) to DONQ52 | Up to 246 days |
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