Gastric Gluten-Degradation Activity of PvP001

NCT03594331 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: HUM00122254
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Number of treatment emergent adverse events

  The number of treatment emergent adverse events at each dosage level

  2 weeks from each exposure.

• Percentage of treatment emergent adverse events

  The percentage of treatment emergent adverse events at each dosage level

  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.

  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

  12 months

Study Arms (3)

Gluten Exposure Group 1

EXPERIMENTAL

This group will ingest the drug and then consume a study meal containing a low level of gluten. In four separate visits, each subject will be administered low-dose PvP001, medium-dose PvP001, high-dose PvP001 and placebo, with blinding to the dose of PvP001 and to which visit placebo is given.

Drug: Low-dose PvP001; Drug: Medium-dose PvP001; Drug: High-dose PvP001; Drug: Placebo

Gluten Exposure Group 2

EXPERIMENTAL

This group will ingest the drug and then consume a study meal containing a medium level of gluten. In four separate visits, each subject will be administered low-dose PvP001, medium-dose PvP001, high-dose PvP001 and placebo, to the dose of PvP001 and to which visit placebo is given.

Drug: Low-dose PvP001; Drug: Medium-dose PvP001; Drug: High-dose PvP001; Drug: Placebo

Gluten Exposure Group 3

EXPERIMENTAL

This group will ingest the drug and then consume a study meal containing a high level of gluten. In four separate visits, each subject will be administered low-dose PvP001, medium-dose PvP001, high-dose PvP001 and placebo, with blinding to the dose of PvP001 and to which visit placebo is given.

Drug: Low-dose PvP001; Drug: Medium-dose PvP001; Drug: High-dose PvP001; Drug: Placebo

Interventions

Low-dose PvP001 DRUG

Low-dose PvP001

Gluten Exposure Group 1; Gluten Exposure Group 2; Gluten Exposure Group 3

Medium-dose PvP001 DRUG

Medium-dose PvP001

Gluten Exposure Group 1; Gluten Exposure Group 2; Gluten Exposure Group 3

High-dose PvP001 DRUG

High-dose PvP001

Gluten Exposure Group 1; Gluten Exposure Group 2; Gluten Exposure Group 3

Placebo DRUG

100 mL liquid with no drug

Gluten Exposure Group 1; Gluten Exposure Group 2; Gluten Exposure Group 3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers;
• Able to maintain a gluten-free diet (GFD) for 24 hours prior to each of visits 1-4;
• Able to abstain from alcohol consumption 72 hours before and 72 hours after each visit;
• Able to tolerate the placement, presence, and manipulation of an oro-gastro-duodenal (OGD) tube;
• Women of child-bearing potential and men whose partners are women of child-bearing potential must be willing to use acceptable birth control for the duration of the study;
• Able to read and understand English;
• Able to provide written informed consent

You may not qualify if:

• Any condition or abnormality, current or past, that, in the opinion of the investigator, would compromise the safety of the subject, or would interfere with or complicate study procedures or assessments.
• No current or recent (within 14 days prior to each study visit, clinical laboratory testing, and ECG) use of over-the-counter or prescription medications via any route of administration, except for oral contraceptives for birth control (provided they have been used regularly for at least the past 3 months). Other medications used regularly at stable doses may be acceptable at the discretion of the study doctor.
• Current symptoms of congestion, upper respiratory tract infection, or acute illness
• Chronic viral infection or immunodeficiency condition
• Any female who is pregnant, planning to become pregnant during the study, or breast-feeding
• History of intolerance, hypersensitivity, or reaction to wheat or other grains, gluten, or any other food or food ingredient (including an additive or preservative) in the study meal;
• Receipt of an investigational medication within four weeks prior to the screening visit or from the screening visit through the final visit;
• Alcohol consumption \>5 drinks/week or any alcohol consumption within the 72 hours prior to each study exposure visit or a positive breathalyzer test result at any study visit;
• Illicit or recreational drug use in the past 12 months or positive urine drug screen at the screening visit;
• History of smoking, nicotine, or tobacco use in the past 12 months;
• History or high risk of noncompliance with treatment or visits.

Sponsors & Collaborators

• Danielle Kim Turgeon: lead
• PvP Biologics, Inc.: collaborator

Study Sites (1)

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Digestive System Diseases

Study Officials

• Danielle Kim Turgeon, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: June 21, 2018
• First Posted: July 20, 2018
• Study Start: May 25, 2018
• Primary Completion: February 6, 2019
• Study Completion: February 6, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

US (1)