Chugai
Are You Eligible?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
Status
Recruitment
Total participants required
Study location
Study type
Patient group
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
Eligibility
- 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.