Chugai - Wesley Research Institute
Wesley Research Institute

The research project is to evaluate the safety, effectiveness, immune response and blood levels of a single subcutaneous (SC) dose of DONQ52, an investigational product, versus a placebo for use in the treatment of Coeliac Disease.

Research Objectives





Total participants required


Study location

Wesley Research Institute

Study type

Industry Sponsored

Patient group

Individuals with well controlled medically diagnosed Coeliac Disease (CeD).

About this clinical trial

DONQ52 is a new experimental drug that is expected to suppress the gluten specific T-cell activity and reduce your illness/symptoms of coeliac disease when gluten is accidentally ingested by binding with the complex of coeliac human leukocyte antigen (HLA) and gluten peptide.

The main goals of this study are to find out:

  • How safe DONQ52 is
  • How quickly DONQ52 is absorbed and removed by your body (this is called pharmacokinetics). This will be measured by changes in the amount of DONQ52 in your blood.
  • How DONQ52 reacts in the body compared to placebo in people who have Coeliac Disease in response to a gluten challenge.

For more trial information visit ACTRN12624000316505


  • Aged between 18 and 70 years old.
  • Have been medically diagnosed with Coeliac disease.
  • Have a body mass index (BMI) of 18 to 35 km/m2 at screening.
  • Have been on a gluten-free diet for at least 12 months.
  • You are willing to consume food containing gluten protein as part of a 3-day gluten challenge.

Lead investigator

  • Dr Jennifer Schafer

Clinical trial coordinator

  • Chris Henderson

Technical title

A Phase IC, Randomized, Double Blind, Placebo Controlled, Multi-Center Study To Evaluate The Safety, Pharmacokinetics, Immunogenicity, and Biological Effects of DONQ52 In Celiac Disease Patients with Gluten Challenge

Register your interest

If you would like more information about this clinical trial, please complete the contact form below.

You must be based in the Greater Brisbane region to be eligible for this study.
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Which if the following accurately describes you?(Required)

Have you been medically diagnosed with Coeliac Disease?(Required)
Have you been eating a gluten-free diet for at least 12 months?(Required)
Are you willing to consume food containing gluten protein as part of a 3-day gluten challenge?(Required)
Would you like to be updated on the progress of our research?(Required)
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