NCT04593251

Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis

A Multicentre, SAD, and MAD Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IV Treatment of CALY-002 in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Calypso Biotech BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a single and multiple ascending study to characterize the safety, PK, PD and clinical effect in healthy volunteers and participants with Celiac Disease and Eosinophilic Esophagitis.

Detailed description

This is a multi-site, randomized, placebo controlled single and multiple dose escalation study of an anti-IL-15 mAb (CALY-002). The study initiates as placebo controlled, randomized trial with a single ascending dosing part in healthy subjects and commences with a multiple ascending dosing part in participants with Celiac Disease undergoing a gluten challenge and includes open label multiple dose expansion cohorts in participants with Eosinophilic Esophagitis.

Conditions

• Eosinophilic Esophagitis
• Celiac Disease

Interventions

Type	Name	Description
BIOLOGICAL	CALY-002	1-hour intravenous infusion
BIOLOGICAL	Placebo	1-hour intravenous infusion

Timeline

• Start date: 2020-09-28
• Primary completion: 2024-04-02
• Completion: 2024-04-02
• First posted: 2020-10-19
• Last updated: 2024-04-09

Locations

13 sites across 5 countries: Belgium, Finland, Germany, Netherlands, Norway