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Gastric Gluten-Degradation Activity of PvP001

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ClinicalTrials.gov Identifier: NCT03594331
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
PvP Biologics, Inc.
Information provided by (Responsible Party):
Danielle Kim Turgeon, University of Michigan

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.

Condition or disease Intervention/treatment Phase
Digestive System Disease Drug: Low-dose PvP001 Drug: Medium-dose PvP001 Drug: High-dose PvP001 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Phase I, First-in-Human Single Center Study in Healthy Adult Volunteers to Assess the Gastric Gluten-Degradation Activity of PvP001
Actual Study Start Date : May 25, 2018
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : May 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gluten Exposure Group 1
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
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

Experimental: Gluten Exposure Group 2
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
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

Experimental: Gluten Exposure Group 3
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
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




Primary Outcome Measures :
  1. Number of treatment emergent adverse events [ Time Frame: 2 weeks from each exposure. ]
    The number of treatment emergent adverse events at each dosage level

  2. Percentage of treatment emergent adverse events [ Time Frame: 2 weeks from each exposure. ]
    The percentage of treatment emergent adverse events at each dosage level

  3. Side effects of study drug [ Time Frame: 12 months ]
    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.

  4. Efficacy as measured by the lowest dose to degrade highest amount of gluten [ Time Frame: 12 months ]
    The lowest dose of PvP001 that degrades the highest amount of gluten in a standardized study meal



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594331


Contacts
Contact: Elaine Brady, MBA 734-647-4794 embrady@med.umich.edu

Locations
United States, Michigan
Michigan Medicine Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Danielle Kim Turgeon, MD         
Sponsors and Collaborators
Danielle Kim Turgeon
PvP Biologics, Inc.
Investigators
Principal Investigator: Danielle Kim Turgeon, MD University of Michigan

Responsible Party: Danielle Kim Turgeon, Professor of Internal Medicine, University of Michigan
ClinicalTrials.gov Identifier: NCT03594331     History of Changes
Other Study ID Numbers: HUM00122254
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases