This is a single blind, dose escalating, placebo-controlled, crossover study of gluten-degrading drug PvP001 administered to healthy volunteers (age 18-64 years). Subjects will be randomized to one of three groups representing different levels of gluten exposure - low, medium, or high - in a single meal. Within each gluten exposure group, increasing doses of PvP001 (or placebo) will be administered.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Enrollment
43
Michigan Medicine
Ann Arbor, Michigan, United States
Number of treatment emergent adverse events
The number of treatment emergent adverse events at each dosage level
Time frame: 2 weeks from each exposure.
Percentage of treatment emergent adverse events
The percentage of treatment emergent adverse events at each dosage level
Time frame: 2 weeks from each exposure.
Side effects of study drug
Side effects are assessed by the PI using a 5-scale, 9-question Gastrointestinal Symptoms Questionnaire (GSQ) to be self-administered by the subject at 16 time-points throughout the five-visit (including screening) study. Each of the 9 questions will be given a numerical score (0-4 where 0 is none and 4 is very severe) and compared to baseline score and placebo scores any increase of \>1 point over the average baseline and placebo score will be considered an AE and graded based on the severity reported.
Time frame: 12 months
Efficacy as measured by the lowest dose to degrade highest amount of gluten
The lowest dose of PvP001 that degrades the highest amount of gluten in a standardized study meal
Time frame: 12 months
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100 mL liquid with no drug