The trial is taking place at:
N

North Carolina Clinical Research | Raleigh, NC

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

Chugai Pharmaceutical logo

Chugai Pharmaceutical

Status and phase

Enrolling
Phase 1

Conditions

Celiac Disease

Treatments

Drug: DONQ52
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT05425446
DQB101US

Details and patient eligibility

About

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.

Enrollment

56 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

56 participants in 7 patient groups

SAD Cohort 1
Experimental group
Description:
All randomized patients will receive one dose of either DONQ52 Dose A or placebo
Treatment:
Drug: Placebo
Drug: DONQ52
SAD Cohort 2
Experimental group
Description:
All randomized patients will receive one dose of either DONQ52 Dose B or placebo
Treatment:
Drug: Placebo
Drug: DONQ52
SAD Cohort 3
Experimental group
Description:
All randomized patients will receive one dose of either DONQ52 Dose C or placebo
Treatment:
Drug: Placebo
Drug: DONQ52
SAD Cohort 4
Experimental group
Description:
All randomized patients will receive one dose of either DONQ52 Dose D or placebo
Treatment:
Drug: Placebo
Drug: DONQ52
MAD Cohort 1
Experimental group
Description:
All randomized patients will receive multiple dose of either DONQ52 Dose E or placebo
Treatment:
Drug: Placebo
Drug: DONQ52
MAD Cohort 2
Experimental group
Description:
All randomized patients will receive multiple dose of either DONQ52 Dose F or placebo
Treatment:
Drug: Placebo
Drug: DONQ52
MAD Cohort 3
Experimental group
Description:
All randomized patients will receive multiple dose of either DONQ52 Dose G or placebo
Treatment:
Drug: Placebo
Drug: DONQ52

Trial contacts and locations

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Central trial contact

Clinical trials information

Data sourced from clinicaltrials.gov

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