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Chugai Study (Asymptomatic)

A Phase IC, randomized, double-blind, placebo-controlled, multicenter study.

Study Title

A Phase IC, randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety, pharmacokinetics, immunogenicity, and biological effects of DONQ52 in celiac disease patients with gluten challenge.

Purpose of Study

This study will evaluate the safety, pharmacokinetics (PK), immunogenicity, and biological effects of DONQ52 in celiac disease (CeD) patients with gluten challenge in comparison with placebo. Specific objectives and corresponding endpoints for the study are outlined below.

Eligibility

You may be eligible for the study if you meet the following criteria.

  • People who are currently asymptomatic or have minimal symptoms.
  • Aged between 18 and 70 years old.
  • Have been medically diagnosed with Coeliac disease.
  • Have a body mass index (BMI) of 18 to 35 kg/m2 at screening.
  • Have been on a gluten-free diet for at least 12 months.
  • Willing to consume food containing gluten protein as part of a 3-day gluten challenge.

How long will this study take?

If eligible for the study, your participation is expected to last approximately 30 weeks.


Please contact CDH Research Institute on 07 5408 0900 for additional information or use the email link below. You can also share details of this study to social media via the links below?

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