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

Chugai Pharmaceutical

Status and phase: Active, not recruiting; Phase 1

Conditions: Celiac Disease

Treatments: Drug: Placebo; Drug: DONQ52

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

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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: DONQ52

Drug: Placebo

SAD Cohort 2

Experimental group

Description:

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

Treatment:

Drug: DONQ52

Drug: Placebo

SAD Cohort 3

Experimental group

Description:

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

Treatment:

Drug: DONQ52

Drug: Placebo

SAD Cohort 4

Experimental group

Description:

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

Treatment:

Drug: DONQ52

Drug: Placebo

MAD Cohort 1

Experimental group

Description:

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

Treatment:

Drug: DONQ52

Drug: Placebo

MAD Cohort 2

Experimental group

Description:

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

Treatment:

Drug: DONQ52

Drug: Placebo

MAD Cohort 3

Experimental group

Description:

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

Treatment:

Drug: DONQ52

Drug: Placebo