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Clinical trial

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)

ID
Name
DQB101US
Description
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 arms
Trial start
2022-09-19
Estimated PCD
2024-05-31
Trial end
2024-05-31
Status
Recruiting
Phase
Early phase I
Treatment
DONQ52
Subcutaneous (SC) injection
Arms:
MAD Cohort 1, MAD Cohort 2, MAD Cohort 3, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4
Placebo
Subcutaneous (SC) injection
Arms:
MAD Cohort 1, MAD Cohort 2, MAD Cohort 3, SAD Cohort 1, SAD Cohort 2, SAD Cohort 3, SAD Cohort 4
Size
56
Primary endpoint
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
Up to 246 days
Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation)
Up to 246 days
Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)
Up to 246 days
Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis)
Up to 246 days
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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 56, 'type': 'ESTIMATED'}}
Updated at
2023-11-28

1 organization

2 products

1 indication

Organization
Chugai Pharmaceutical
Product
Placebo
Indication
Celiac Disease
Product
DONQ52