Clinical trial NCT03594331: Gastric Gluten-Degradation Activity of PvP001
Official title: A Phase I, First-in-Human Single Center Study in Healthy Adult Volunteers to Assess the Gastric Gluten-Degradation Activity of PvP001
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Digestive System Disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: PvP Biologics, Inc.
First posted: 2018-07-20
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Number of treatment emergent adverse events
timeFrame: 2 weeks from each exposure.
measure: Percentage of treatment emergent adverse events
timeFrame: 2 weeks from each exposure.
measure: Side effects of study drug
timeFrame: 12 months
measure: Efficacy as measured by the lowest dose to degrade highest amount of gluten
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Danielle Kim Turgeon, MD
role: PRINCIPAL_INVESTIGATOR
References: