DONQ52 for Celiac Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Jacksonville Center for Clinical Research, Jacksonville, FL
Celiac Disease
DONQ52 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 6 Secondary · Reporting Duration: Up to 246 days

Up to 246 days
Immunogenicity
Incidence and severity of treatment-emergent adverse events (TEAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or higher
Pharmacokinetics; Area under the serum concentration time curve [AUC]
Pharmacokinetics; Half life [T1/2]
Pharmacokinetics; Maximum serum concentration [Cmax]
Pharmacokinetics; Serum DONQ52 concentration
Pharmacokinetics; Time to maximum serum concentration [Tmax]
Safety as assessed by Electrocardiograms (ECGs; QT interval, heart rate)
Safety as assessed by Laboratory tests (hematology, blood chemistry, coagulation and urinalysis)
Safety as assessed by Vital signs (blood pressure, body temperature, pulse rate, respiratory rate, percutaneous oxygen saturation)

Trial Safety

Trial Design

7 Treatment Groups

MAD Cohort 3
1 of 7
SAD Cohort 1
1 of 7
SAD Cohort 4
1 of 7
MAD Cohort 1
1 of 7
MAD Cohort 2
1 of 7
SAD Cohort 2
1 of 7
SAD Cohort 3
1 of 7
Experimental Treatment

56 Total Participants · 7 Treatment Groups

Primary Treatment: DONQ52 · Has Placebo Group · Phase 1

MAD Cohort 3Experimental Group · 2 Interventions: Placebo, DONQ52 · Intervention Types: Drug, Drug
SAD Cohort 1Experimental Group · 2 Interventions: Placebo, DONQ52 · Intervention Types: Drug, Drug
SAD Cohort 4Experimental Group · 2 Interventions: Placebo, DONQ52 · Intervention Types: Drug, Drug
MAD Cohort 1Experimental Group · 2 Interventions: Placebo, DONQ52 · Intervention Types: Drug, Drug
MAD Cohort 2Experimental Group · 2 Interventions: Placebo, DONQ52 · Intervention Types: Drug, Drug
SAD Cohort 2Experimental Group · 2 Interventions: Placebo, DONQ52 · Intervention Types: Drug, Drug
SAD Cohort 3Experimental Group · 2 Interventions: Placebo, DONQ52 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 246 days
Closest Location: Jacksonville Center for Clinical Research · Jacksonville, FL
Photo of Jacksonville 1Photo of Jacksonville 2Photo of Jacksonville 3
2003First Recorded Clinical Trial
2 TrialsResearching Celiac Disease
144 CompletedClinical Trials

Who is running the clinical trial?

Chugai PharmaceuticalLead Sponsor
86 Previous Clinical Trials
20,006 Total Patients Enrolled
Sponsor Chugai Pharmaceutical Co. LtdStudy Directorclinical-trials@chugai-pharm.co.jp
7 Previous Clinical Trials
587 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a history of medically diagnosed celiac disease based on biopsies and positive celiac serology.
You have a specific HLA-DQ2.5 genotype.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.