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Gastric Gluten-Degradation Activity of PvP001

NCT03594331 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2019-02-15

No results posted yet for this study

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.

Conditions

  • Digestive System Disease

Interventions

DRUG

Low-dose PvP001

Low-dose PvP001

DRUG

Medium-dose PvP001

Medium-dose PvP001

DRUG

High-dose PvP001

High-dose PvP001

DRUG

Placebo

100 mL liquid with no drug

Sponsors & Collaborators

  • PvP Biologics, Inc.

    collaborator INDUSTRY

  • Danielle Kim Turgeon

    lead OTHER

Principal Investigators

  • Danielle Kim Turgeon, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-25
Primary Completion
2019-02-06
Completion
2019-02-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03594331 on ClinicalTrials.gov