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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Chugai Pharmaceutical
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Sponsor Chugai Pharmaceutical Co. Ltd
Principal Investigator Affiliation
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Celiac Disease
Arms & Interventions


Experimental: SAD Cohort 1

All randomized patients will receive one dose of either DONQ52 Dose A or placebo

Experimental: SAD Cohort 2

All randomized patients will receive one dose of either DONQ52 Dose B or placebo

Experimental: SAD Cohort 3

All randomized patients will receive one dose of either DONQ52 Dose C or placebo

Experimental: SAD Cohort 4

All randomized patients will receive one dose of either DONQ52 Dose D or placebo

Experimental: MAD Cohort 1

All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo

Experimental: MAD Cohort 2

All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo

Experimental: MAD Cohort 3

All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo


Drug: - DONQ52

Subcutaneous (SC) injection

Drug: - Placebo

Subcutaneous (SC) injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Pinnacle Research Group, Anniston, Alabama




Pinnacle Research Group

Anniston, Alabama, 36207

Diablo Clinical Research, Walnut Creek, California




Diablo Clinical Research

Walnut Creek, California, 94598

Jacksonville, Florida




Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216

Clinical Site Partners - Orlando, Winter Park, Florida




Clinical Site Partners - Orlando

Winter Park, Florida, 32789

Velocity Clinical Research - Boise, Meridian, Idaho




Velocity Clinical Research - Boise

Meridian, Idaho, 83642

Tandem Clinical Research, Marrero, Louisiana




Tandem Clinical Research

Marrero, Louisiana, 70072

Morehead City, North Carolina




Lucas Research - Diabetes & Endocrinology Consultants, PC

Morehead City, North Carolina, 28557

North Carolina Clinical Research, Raleigh, North Carolina




North Carolina Clinical Research

Raleigh, North Carolina, 27607

Aventiv Research, Inc., Columbus, Ohio




Aventiv Research, Inc.

Columbus, Ohio, 43213

Velocity Clinical Research, Anderson, Anderson, South Carolina




Velocity Clinical Research, Anderson

Anderson, South Carolina, 29621

Alliance for Multispecialty Research, Knoxville, Tennessee




Alliance for Multispecialty Research

Knoxville, Tennessee, 37920

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