DONQ52 for Celiac Disease

Recruiting at 22 trial locations

Overseen By Clinical trials information

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Chugai Pharmaceutical

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called DONQ52 in patients with well-managed celiac disease. The study has two parts: one where patients receive single doses and another where they receive multiple doses. The goal is to see if the drug is safe and well-tolerated.

Research Team

Sponsor Chugai Pharmaceutical Co. Ltd

Principal Investigator

[e-mail]

Eligibility Criteria

This trial is for people with celiac disease who have mild symptoms or are well-controlled, carry the HLA-DQ2.5 gene, and have been on a gluten-free diet for at least one year. Participants must also have a medical diagnosis confirmed by biopsies and positive serology tests. Those with refractory celiac disease or positive serology markers (tissue transglutaminase-2, deamidated gliadin peptide-IgA/G) cannot join.

Inclusion Criteria

Are you between the ages of 18-70 years old?

You have been diagnosed with Celiac Disease

I only have mild symptoms of celiac disease.

Treatment Details

Interventions

• DONQ52 (Unknown)
• Placebo (Drug)

Trial Overview The study is testing DONQ52's safety and how it's processed in the body in two parts: Part A gives patients one dose to see how they react, while Part B gives them multiple doses over time. The effects of DONQ52 will be compared to a placebo (a treatment without any active drug).

Participant Groups

Group I: SAD Cohort 4 Experimental Treatment 2 Interventions

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

Group II: SAD Cohort 3 Experimental Treatment 2 Interventions

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

Group III: SAD Cohort 2 Experimental Treatment 2 Interventions

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

Group IV: SAD Cohort 1 Experimental Treatment 2 Interventions

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

Group V: MAD Cohort 3 Experimental Treatment 2 Interventions

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

Group VI: MAD Cohort 2 Experimental Treatment 2 Interventions

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

Group VII: MAD Cohort 1 Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Chugai Pharmaceutical

Lead Sponsor

Trials

105

Recruited

25,000+

Dr. Osamu Okuda

Chugai Pharmaceutical

Chief Executive Officer since 2020

MD from Kyoto University

Dr. Mariko Y. Momoi

Chugai Pharmaceutical

Chief Medical Officer

MD from Jichi Medical University