Assess the Gluten Degradation Activity of PvP001 and PvP002 in Healthy Adult Volunteers

This study has two parts. Each part of the study begins with a Screening Period of up to 4
weeks to allow for completion of screening procedures and subject scheduling. Each subject
will be screened by means of medical history, medication review, Gastrointestinal Symptoms
Questionnaire (GSQ), physical examination, vital signs, weight, height, laboratory tests, and
ECG. The GSQ is being used as a separate safety monitoring tool in this study to ensure that
all gastrointestinal complaints are reported by the subject.

Following completion of all screening procedures, eligible subjects will be enrolled in the
study. Part 1 of the study in healthy subjects will be completed prior to enrollment of any
subject in Part 2 of the study. A subject enrolled in Part 1 of the study will participate in
one of five dose Cohorts. Enrollment of healthy subjects in each of the five dose Cohorts
will occur sequentially. Enrollment of patients with CeD in each of the five dose Cohorts
will occur sequentially, but each of these dose Cohorts will be open to enrollment only after
demonstration of the safety and tolerability of the same dose level in healthy subjects. A
healthy subject enrolled in Part 2 of the study will participate in one of two Groups; within
Group 1 and Group 2, each subject will be randomized to the treatment order. Enrollment of
subjects in Group 1 and Group 2 may occur in parallel. A subject may participate in only one
part/group of the study (i.e., either Part 1, Part 2 Group 1, or Part 2 Group 2).

Inclusion Criteria:

Part 1 and Part 2

- Male or female age 18- 59 years, inclusive

- No relevant gastrointestinal symptoms

- Able to abstain from alcohol for 72 hours prior to the Screening Visit, Cohort
Treatment Day, and Final Safety Visit (Part 2), and for 72 hours after the Cohort
Treatment Day

- A female subject must have a negative pregnancy test at Screening and prior to each
treatment day visit, and agree to birth control measures (e.g., abstinence, a stable
hormonal contraceptive, double-barrier method, or vasectomy in partner) for the study
duration

- A male subject must agree to acceptable birth control measures (e.g., abstinence,
latex condom, or vasectomy), or must have a female partner who will continue birth
control measures (e.g., abstinence, a stable hormonal contraceptive, or double-barrier
method) for the study duration

- Able to read and understand English

- Able to provide written informed consent

Additional Inclusion Criteria for Part 1 and Part 2 Healthy Adult Volunteers

- No use of over-the-counter or prescription medication, except for birth control
medications for the duration of the study

- No history of gastrointestinal diseases or disorders

- No history of intolerance, sensitivity, or reactions to gluten or any other food or
food ingredient

- Able to maintain a gluten-free diet for 24 hours prior to the designated study visits

Additional Inclusion Criteria for Part 1 Patients with Celiac Disease

- Documented history of Celiac Disease in medical records

- Maintaining a gluten-free diet for ≥6 months

- No use of over-the-counter or prescription medication, except for birth control
medications and those allowed by the study doctor, for the duration of the study.

- No history of gastrointestinal diseases or disorders, other than Celiac Disease

- No history of intolerance, hypersensitivity, or reaction to any food or food
ingredient

- Able to continue a gluten-free diet for the duration of the study

Exclusion Criteria:

Part 1 and Part 2

- Current symptoms or signs of illness

- Chronic viral infection or immunodeficiency condition

- Any female who is pregnant, planning to become pregnant during the study, or
breast-feeding; any male who is planning to father a child during the study

- Receipt (or planned receipt) of another investigational medication within 4 weeks
prior to the Screening Visit through the duration of the study

- Alcohol consumption >5 drinks/week, alcohol consumption within 72 hours prior to any
study visit, or a positive alcohol breathalyzer test at any study visit

- History of illicit or recreational drug use within the three years prior to the
Screening Visit, or a positive urine drug screen at any study visit

- Use of tobacco or nicotine products, including smoking, smokeless tobacco,
e-cigarettes, or nicotine replacement products within 12 months prior to the Screening
Visit through the duration of the study