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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
73
Cliniques Universitaires Saint-Luc - Hospital
Brussels, Belgium
UZ Leuven
Leuven, Belgium
Tampere University Hospital
Tampere, Finland
Incidence of treatment-emergent adverse event
Time frame: through study completion, an average of 3 months post last dose
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Charite
Berlin, Germany
Universitatsklinikum Erlangen - Hospital
Erlangen, Germany
Universitätsklinikum Freiburg - Hospital
Freiburg im Breisgau, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz - Hospital
Mainz-GE, Germany
Klinikum rechts der Isa der Technischen Universitaet Muenchen - Hospital
Munich, Germany
AMC
Amsterdam, Netherlands
Ziekenhuis Rijnstate - Hospital
Arnhem, Netherlands
...and 3 more locations