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

• Status: Not yet recruiting
• Trial end date: 2024-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chugai Pharmaceutical

Criteria

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)