Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis
NCT04593251 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2024-04-09
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.
Conditions
- Eosinophilic Esophagitis
- Celiac Disease
Interventions
- BIOLOGICAL
-
CALY-002
1-hour intravenous infusion
- BIOLOGICAL
-
1-hour intravenous infusion
Sponsors & Collaborators
-
Calypso Biotech BV
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-09-28
- Primary Completion
- 2024-04-02
- Completion
- 2024-04-02
Countries
- Belgium
- Finland
- Germany
- Netherlands
- Norway
Study Locations
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