DONQ52 for Celiac Disease

Recruiting at 22 trial locations

Overseen By Clinical trials information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Chugai Pharmaceutical

Disqualifiers: Refractory celiac, Positive serology

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

56 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

You have been diagnosed with Celiac Disease

I only have mild symptoms of celiac disease.

I have the HLA-DQ2.5 gene.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD) Treatment

Participants receive a single dose of either DONQ52 or placebo in ascending dose cohorts

4-8 weeks

Multiple Ascending Dose (MAD) Treatment

Participants receive multiple doses of either DONQ52 or placebo in ascending dose cohorts

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 246 days

Treatment Details

Interventions

• DONQ52
• Placebo

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