Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
Key facts
- Who runs it
- Chugai Pharmaceutical
- Where
- Anderson, Anniston, Columbus, Dayton, Denver, Great Neck, Jacksonville, Knoxville, Leesburg, Marrero, Meridian, Morehead City, New York, Ogden, Raleigh, Rochester, Waco, and Winter Park, United StatesSee the 18 sitesAlso in 1 other country, 3 sites
- Trial code
- Status
- Completed
- Phase
- Phase 1
- People taking part
- 56 people enrolled
- Started
- 19 Sept 2022
- Ended
- 17 Jan 2025
- Type of study
- Interventional, 7 groups
- Treatments tested
- DONQ52
- Placebo
- Record updated
- 31 January 2025
Who can take part
- Age
- 18 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- Refractory celiac disease
- Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)
Where in United States
Also in 1 other country, 3 sites
- Velocity Clinical Research, AndersonAnderson, United States
- Pinnacle Research GroupAnniston, United States
- Aventiv Research IncColumbus, United States
- Digestive Specialists IncDayton, United States
- Mountain View Clinical ResearchDenver, United States
- Long Island Gastrointestinal Research GroupGreat Neck, United States
- Jacksonville Center for Clinical ResearchJacksonville, United States
- Alliance for Multispecialty ResearchKnoxville, United States
- Clinical Site PartnersLeesburg, United States
- Tandem Clinical ResearchMarrero, United States
- Velocity Clinical Research, BoiseMeridian, United States
- Lucas Research - Diabetes & Endocrinology Consultants, PCMorehead City, United States
- Columbia University Medical CenterNew York, United States
- Care Access ResearchOgden, United States
- North Carolina Clinical ResearchRaleigh, United States
- Mayo Clinic - RochesterRochester, United States
- Digestive Research of Central TexasWaco, United States
- Clinical Site Partners - OrlandoWinter Park, United States
About the trial
What the trial wants to find out
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.
The 7 groups in the trial
- SAD Cohort 1Treatment being tested
All randomized patients will receive one dose of either DONQ52 Dose A or placebo
Treatment: DONQ52 and Placebo
- SAD Cohort 2Treatment being tested
All randomized patients will receive one dose of either DONQ52 Dose B or placebo
Treatment: DONQ52 and Placebo
- SAD Cohort 3Treatment being tested
All randomized patients will receive one dose of either DONQ52 Dose C or placebo
Treatment: DONQ52 and Placebo
- SAD Cohort 4Treatment being tested
All randomized patients will receive one dose of either DONQ52 Dose D or placebo
Treatment: DONQ52 and Placebo
- MAD Cohort 1Treatment being tested
All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo
Treatment: DONQ52 and Placebo
- MAD Cohort 2Treatment being tested
All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo
Treatment: DONQ52 and Placebo
- MAD Cohort 3Treatment being tested
All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo
Treatment: DONQ52 and Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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)
- Record updated
- 31 January 2025