A Study of Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of KAN-101 in People With Celiac Disease

• Status: Not yet recruiting
• Trial end date: 2025-04-02
• Target enrollment: 0
• Participant gender: All

Summary

This study is to evaluate the Pharmacodynamic (PD), safety, tolerability, Pharmacokinetic (PK), and plasma biomarker response of KAN-101 in participants with Celiac Disease (CeD).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

Criteria

Inclusion Criteria:

• Previous diagnosis of celiac disease based on histology and positive celiac serology

• HLA-DQ2.5 genotype

• Gluten-free diet for at least 12 months

• Negative or weak positive for transglutaminase IgA and negative or weak positive for DGP-IgA/IgG during screening

Exclusion Criteria:

• Refractory celiac disease

• HLA-DQ8 genotype

• Previous oral gluten challenge within 12 months

• Selective IgA deficiency

• Diagnosis of Type-1 diabetes

• Active gastrointestinal diseases

• History of dermatitis herpetiformis