This is a Phase 0, Double-blind study that will assess the effect of in vitro treatment of gluten with ALV003 or with placebo when ingested by CD Subjects.
The primary objective of this study is to compare the effects of gluten treated with ALV003 vs placebo: * The clinical response by symptom measurement before and after oral challenge * The immune response measured by ELISPOT testing and serology The secondary objective of the study is to * Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo
Study Type
OBSERVATIONAL
Enrollment
20
Nucleus Networks Limited
Melbourne, Victoria, Australia
The clinical response by symptom measurement before and after oral challenge
Time frame: Day 1 and Day 6
The immune response measured by ELISPOT testing and celiac disease serology
Time frame: Prior to and post 3-day gluten challenge
Describe the immunotoxic epitope profile of gluten digests with ALV003 compared with placebo
Time frame: Day 1 and Day 14
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