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)
1 other identifier
interventional
56
2 countries
21
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2022
Typical duration for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 13, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedStudy Start
First participant enrolled
September 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2025
CompletedJanuary 31, 2025
January 1, 2025
1.9 years
June 13, 2022
January 29, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)
Abnormality in Electrocardiograms (ECGs)
Up to 246 days
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 Outcomes (6)
Pharmacokinetics; Serum DONQ52 concentration
Up to 246 days
Pharmacokinetics; Maximum serum concentration [Cmax]
Up to 246 days
Pharmacokinetics; Time to maximum serum concentration [Tmax]
Up to 246 days
Pharmacokinetics; Area under the serum concentration time curve [AUC]
Up to 246 days
Pharmacokinetics; Half life [T1/2]
Up to 246 days
- +1 more secondary outcomes
Study Arms (7)
SAD Cohort 1
EXPERIMENTALAll randomized patients will receive one dose of either DONQ52 Dose A or placebo
SAD Cohort 2
EXPERIMENTALAll randomized patients will receive one dose of either DONQ52 Dose B or placebo
SAD Cohort 3
EXPERIMENTALAll randomized patients will receive one dose of either DONQ52 Dose C or placebo
SAD Cohort 4
EXPERIMENTALAll randomized patients will receive one dose of either DONQ52 Dose D or placebo
MAD Cohort 1
EXPERIMENTALAll randomized patients will receive multiple dose of either DONQ52 Dose E or placebo
MAD Cohort 2
EXPERIMENTALAll randomized patients will receive multiple dose of either DONQ52 Dose F or placebo
MAD Cohort 3
EXPERIMENTALAll randomized patients will receive multiple dose of either DONQ52 Dose G or placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Refractory celiac disease
- Positive for any of the 3 serology (-Tissue transglutaminase-2,- Deamidated gliadin peptide-IgA, and deamidated gliadin peptide-IgG)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Pinnacle Research Group
Anniston, Alabama, 36207, United States
Mountain View Clinical Research
Denver, Colorado, 80209, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Clinical Site Partners
Leesburg, Florida, 34748, United States
Clinical Site Partners - Orlando
Winter Park, Florida, 32789, United States
Velocity Clinical Research - Boise
Meridian, Idaho, 83642, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55095, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, 11023, United States
Columbia University Medical Center
New York, New York, 10019, United States
Lucas Research - Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, 28557, United States
North Carolina Clinical Research
Raleigh, North Carolina, 27607, United States
Aventiv Research, Inc.
Columbus, Ohio, 43213, United States
Digestive Specialists Inc
Dayton, Ohio, 45414, United States
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621, United States
Alliance for Multispecialty Research
Knoxville, Tennessee, 37920, United States
Digestive Research of Central Texas
Waco, Texas, 76712, United States
Care Access Research
Ogden, Utah, 84403, United States
Campbelltown Hospital
Campbelltown, New South Wales, 2560, Australia
University of Sunshine Coast Clinical Trials Centre - Morayfield
Morayfield, Queensland, 4506, Australia
Linear Clinical Research
Nedlands, Western Australia, 6009, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sponsor Chugai Pharmaceutical Co. Ltd
clinical-trials@chugai-pharm.co.jp
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2022
First Posted
June 21, 2022
Study Start
September 19, 2022
Primary Completion
August 9, 2024
Study Completion
January 17, 2025
Last Updated
January 31, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds\_request.html).