Gastric Gluten-Degradation Activity of PvP001

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.