drugset / Trial / NCT03594331

Gastric Gluten-Degradation Activity of PvP001

NCT03594331 ↗

Phase 1 Terminated 43 enrolled Danielle Kim Turgeon PvP Biologics, Inc. · collab
RandomizedCrossoverSingle-blindBasic science

Summary

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.

Timeline

Start
2018-05-25
Primary completion
2019-02-06
Completion
2019-02-06

Outcome

Outcome not reported

Stopped (Business): “Funding stopped”

Drugs

EvaluationDrugModalityDoseRoute
Subject PvP001 Unknown — —