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OpenTrials
Completed

NCT Number: NCT05425446

Study of the Safety, Tolerability, Pharmacokinetics and Biomarker of DONQ52 in Celiac Disease Patients

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.

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Key information

Conditions

Celiac Disease Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Campbelltown Hospital, Campbelltown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

DONQ52

Drug

Subcutaneous (SC) injection

Placebo

Drug

Subcutaneous (SC) injection

Primary outcomes

  1. Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher

    Time frame: Up to 246 days

    Incidence and severity of TEAEs and its relationship to the study drugs

  2. Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation)

    Time frame: Up to 246 days

    Abnormality in vital signs

  3. Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)

    Time frame: Up to 246 days

    Abnormality in Electrocardiograms (ECGs)

  4. Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis)

    Time frame: Up to 246 days

    Incidence of laboratory abnormalities, based on clinical laboratory tests

Secondary outcomes

  1. Pharmacokinetics; Serum DONQ52 concentration

    Time frame: Up to 246 days

    Serum DONQ52 concentrations over time

  2. Pharmacokinetics; Maximum serum concentration [Cmax]

    Time frame: Up to 246 days

    Cmax of DONQ52

  3. Pharmacokinetics; Time to maximum serum concentration [Tmax]

    Time frame: Up to 246 days

    Tmax of DONQ52

  4. Pharmacokinetics; Area under the serum concentration time curve [AUC]

    Time frame: Up to 246 days

    AUC of DONQ52

  5. Pharmacokinetics; Half life [T1/2]

    Time frame: Up to 246 days

    T1/2 of DONQ52

  6. Immunogenicity

    Time frame: Up to 246 days

    Prevalence and incidence of anti-drug antibodies (ADAs) to DONQ52

Sponsors and collaborators

Lead sponsor

Chugai Pharmaceutical

Industry

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 21, 2022
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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