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NCT05425446 Clinical Trial

Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients

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)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05425446
Other study ID # DQB101US
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 19, 2022
Est. completion date May 31, 2024

Study information
Verified date November 2023
Source Chugai Pharmaceutical
Contact Clinical trials information
Phone only use Email
Email clinical-trials@chugai-pharm.co.jp
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DONQ52
Subcutaneous (SC) injection
• Placebo
Subcutaneous (SC) injection

Locations
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 Diablo Clinical Research, Inc Walnut Creek California
United States Clinical Site Partners - Orlando Winter Park Florida

Sponsors (1)
Lead Sponsor Collaborator
Chugai Pharmaceutical

Countries where clinical trial is conducted

United States,  Australia, 

Outcome
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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