Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
Public ClinicalTrials.gov record NCT05425446. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Study identification
- NCT ID
- NCT05425446
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Chugai Pharmaceutical
- Industry
- Enrollment
- 56 participants
Conditions and interventions
Conditions
Interventions
- DONQ52 Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 18, 2022
- Primary completion
- Aug 8, 2024
- Completion
- Jan 16, 2025
- Last update posted
- Jan 30, 2025
2022 – 2025
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | — |
| Mountain View Clinical Research | Denver | Colorado | 80209 | — |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | — |
| Clinical Site Partners | Leesburg | Florida | 34748 | — |
| Clinical Site Partners - Orlando | Winter Park | Florida | 32789 | — |
| Velocity Clinical Research - Boise | Meridian | Idaho | 83642 | — |
| Tandem Clinical Research | Marrero | Louisiana | 70072 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55095 | — |
| Long Island Gastrointestinal Research Group | Great Neck | New York | 11023 | — |
| Columbia University Medical Center | New York | New York | 10019 | — |
| Lucas Research - Diabetes & Endocrinology Consultants, PC | Morehead City | North Carolina | 28557 | — |
| North Carolina Clinical Research | Raleigh | North Carolina | 27607 | — |
| Aventiv Research, Inc. | Columbus | Ohio | 43213 | — |
| Digestive Specialists Inc | Dayton | Ohio | 45414 | — |
| Velocity Clinical Research, Anderson | Anderson | South Carolina | 29621 | — |
| Alliance for Multispecialty Research | Knoxville | Tennessee | 37920 | — |
| Digestive Research of Central Texas | Waco | Texas | 76712 | — |
| Care Access Research | Ogden | Utah | 84403 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05425446, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 30, 2025 · Synced Jul 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05425446 live on ClinicalTrials.gov.