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

  • End date
    May 31, 2024
  • participants needed
  • sponsor
    Chugai Pharmaceutical
Updated on 9 August 2022
investigational drug
serologic test


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.

Condition Celiac Disease
Treatment Placebo, DONQ52
Clinical Study IdentifierNCT05425446
SponsorChugai Pharmaceutical
Last Modified on9 August 2022


Yes No Not Sure

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)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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