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Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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)

NCT05425446•Chugai Pharmaceutical

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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)

Locations (21)

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

Key Dates

Start Date

September 19, 2022

Primary Completion Date

August 9, 2024

Completion Date

January 17, 2025

Last Updated

January 31, 2025

Enrollment

ACTUAL participants

Conditions

Celiac Disease

Interventions

DONQ52

DRUG

Placebo

DRUG

Study of DONQ52 in Active Celiac Disease

NCT07239336

Celiac Disease

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RECRUITINGNA

GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)

NCT06356220

Celiac Disease in ChildrenNutrition Disorder, Child

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RECRUITINGNA

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of DONQ52 in Active Celiac Disease

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