Clinical trial NCT05425446: Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Celiac Disease
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
timeFrame: Up to 246 days
measure: Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation)
timeFrame: Up to 246 days
measure: Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)
timeFrame: Up to 246 days
measure: Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis)
timeFrame: Up to 246 days
Secondary outcomes:
measure: Pharmacokinetics; Serum DONQ52 concentration
timeFrame: Up to 246 days
measure: Pharmacokinetics; Maximum serum concentration [Cmax]
timeFrame: Up to 246 days
measure: Pharmacokinetics; Time to maximum serum concentration [Tmax]
timeFrame: Up to 246 days
measure: Pharmacokinetics; Area under the serum concentration time curve [AUC]
timeFrame: Up to 246 days
measure: Pharmacokinetics; Half life [T1/2]
timeFrame: Up to 246 days
measure: Immunogenicity
timeFrame: Up to 246 days
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group
state: Alabama
city: Denver
country: United States
facility: Mountain View Clinical Research
state: Colorado
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Leesburg
country: United States
facility: Clinical Site Partners
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners - Orlando
state: Florida
city: Meridian
country: United States
facility: Velocity Clinical Research - Boise
state: Idaho
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Great Neck
country: United States
facility: Long Island Gastrointestinal Research Group
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Morehead City
country: United States
facility: Lucas Research - Diabetes & Endocrinology Consultants, PC
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Columbus
country: United States
facility: Aventiv Research, Inc.
state: Ohio
city: Dayton
country: United States
facility: Digestive Specialists Inc
state: Ohio
city: Anderson
country: United States
facility: Velocity Clinical Research, Anderson
state: South Carolina
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research
state: Tennessee
city: Waco
country: United States
facility: Digestive Research of Central Texas
state: Texas
city: Ogden
country: United States
facility: Care Access Research
state: Utah
city: Campbelltown
country: Australia
facility: Campbelltown Hospital
state: New South Wales
city: Morayfield
country: Australia
facility: University of Sunshine Coast Clinical Trials Centre - Morayfield
state: Queensland
city: Nedlands
country: Australia
facility: Linear Clinical Research
state: Western Australia
Study officials:
affiliation: clinical-trials@chugai-pharm.co.jp
name: Sponsor Chugai Pharmaceutical Co. Ltd
role: STUDY_DIRECTOR
References: