Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Part 1: Number of Participants Reporting One or More Treatment Emergent Adverse Events (TEAEs) for PvP001 and PvP002 |
|
Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) |
|
Primary |
Part 4: Number of Participants Reporting One or More TEAEs for PvP003 After Multiple Doses |
|
Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28) |
|
Primary |
Part 1: Number of Participants Reporting One or More Treatment Emergent Serious Adverse Events (TESAEs) for PvP001 and PvP002 |
|
Cohort Treatment Day up to 5 days after 24-hour safety assessment on Day 2 (up to Day 7) |
|
Primary |
Part 4: Number of Participants Reporting One or More TESAEs for PvP003 600 mg After Multiple Doses |
|
Day 1 of Cohort Treatment Period 1 up to 5 days after the Day 5 of Cohort Treatment Period 2 (up to Day 28) |
|
Primary |
Part 2, Group 1, Cohort 2B: Median Percentage of Gluten Degradation by PvP001 in a Standardized 3 Gram (gm) Gluten-containing Study Meal After Administration of PvP001 |
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using Enzyme-Linked Immunosorbent Assay (ELISA) based on the monoclonal R5 and G12 antibodies. |
Cohort Treatment Day |
|
Primary |
Part 2, Group 2, Cohort 2E: Median Percentage of Gluten Degradation by PvP002 in a Standardized 3 gm Gluten-containing Study Meal After Administration of PvP002 |
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
Cohort Treatment Day |
|
Primary |
Part 2, Group 1, Cohort 2C: Median Percentage of Gluten Degradation by PvP001 in a Standardized 3 gm Gluten-containing Study Meal Following 7 Days of Standard Dose PPI Treatment |
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
Cohort Treatment Day |
|
Primary |
Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 20 Minutes After Administration of PvP001 |
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
Cohort Treatment Day: at 20 minutes post-dose |
|
Primary |
Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP001 |
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
Cohort Treatment Day: at 35 minutes post-dose |
|
Primary |
Part 2, Group 3, Cohort 2G and 2H: Median Percentage of Gluten Degradation by PvP001 300 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP001 |
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
Cohort Treatment Day: at 65 minutes post-dose |
|
Primary |
Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 20 Minutes After Administration of PvP001 |
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
Cohort Treatment Day: at 20 minutes post-dose |
|
Primary |
Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP001 |
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
Cohort Treatment Day: at 35 minutes post-dose |
|
Primary |
Part 2, Group 3, Cohort 2J: Median Percentage of Gluten Degradation by PvP001 900 mg in a Standardized 6 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP001 |
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
Cohort Treatment Day: at 65 minutes post-dose |
|
Primary |
Part 3, Groups 1 to 5, Cohorts 3B, 3D, 3F, 3H and 3J: Median Percentage of Gluten Degradation by PvP003 150 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 35 Minutes After Administration of PvP003 |
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
Cohort Treatment Day: at 35 minutes |
|
Primary |
Part 3, Groups 1 to 5, Cohorts 3B, 3D, 3F, 3H and 3J: Median Percentage of Gluten Degradation by PvP003 150 mg and 600 mg in a Standardized 1 gm Gluten-containing Study Meal at 65 Minutes After Administration of PvP003 |
Median percentage degraded relative to placebo was derived using the formula: (1 - [active/placebo])*100. Gluten degradation was assessed using ELISA based on the monoclonal R5 and G12 antibodies. |
Cohort Treatment Day: at 65 minutes |
|
Secondary |
Part 1 and Part 2, Cmax: Maximum Observed Plasma Concentration for PvP001 and PvP002 |
|
Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose |
|
Secondary |
Part 1 and Part 2, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for PvP001 and PvP002 |
|
Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose |
|
Secondary |
Part 1 and Part 2, T(1/2): Terminal Disposition Phase Half-life of PvP001 and PvP002 |
|
Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose |
|
Secondary |
Part 1 and Part 2, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for PvP001 and PvP002 |
|
Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose |
|
Secondary |
Part 1 and Part 2, AUC8: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for PvP001 and PvP002 |
|
Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose |
|
Secondary |
Part 1 and Part 2: Number of Participants With Anti-drug Antibodies (ADA) for PvP001 and PvP002 |
|
At Day 14 and Day 28 |
|
Secondary |
Part 1: Maximum Tolerated Dose (MTD) of PvP001 |
MTD was defined as the maximum dose that was determined to be safe and tolerable for Part 1 (1B-1 and 1B-2, 1C-1 and 1C-2, 1D-1 and 1D-2) in healthy or CeD participants. |
Cohort Treatment Day up to Day 7 |
|
Secondary |
Part 2: Number of Participants Reporting One or More TEAEs and TESAEs for PvP001 and PvP002 |
|
Cohort Treatment Day up to 5 days after the final Cohort Treatment Day (up to Day 22) |
|
Secondary |
Part 3: Number of Participants Reporting One or More TEAEs and TESAEs With PvP003 After a Single Dose |
|
Cohort Treatment Day up to 5 days after final Cohort Treatment Day (up to Day 10) |
|
Secondary |
Part 3, Cmax: Maximum Observed Plasma Concentration for PvP003 150 mg and 600 mg Single Dose |
|
Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post-dose |
|
Secondary |
Part 3, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for PvP003 150 mg and 600 mg Single Dose |
|
Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose |
|
Secondary |
Part 3, T(1/2): Terminal Disposition Phase Half-life of PvP003 150 mg and 600 mg Single Dose |
|
Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose |
|
Secondary |
Part 3, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for PvP003 150 mg and 600 mg Single Dose |
|
Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose |
|
Secondary |
Part 3, AUC8: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for PvP003 150 mg and 600 mg Single Dose |
|
Cohort Treatment Day pre-dose and at multiple time points (up to 480 minutes) post dose |
|
Secondary |
Part 3: Number of Participants With ADA for PvP003 150 mg and 600 mg Single Dose |
|
At Day 14 and Day 28 |
|
Secondary |
Part 4, Cmax: Maximum Observed Plasma Concentration for PvP003 600 mg Multiple Dose |
|
Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose |
|
Secondary |
Part 4, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for PvP003 600 mg Multiple Dose |
|
Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose |
|
Secondary |
Part 4, T(1/2): Terminal Disposition Phase Half-life of PvP003 600 mg Multiple Dose |
|
Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose |
|
Secondary |
Part 4, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for PvP003 600 mg Multiple Dose |
|
Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose |
|
Secondary |
Part 4, AUC8: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for PvP003 600 mg Multiple Dose |
|
Cohort Treatment Days 1 and 5 pre-dose and at multiple time points (up to 240 minutes) post dose |
|
Secondary |
Part 4: Number of Participants With ADA for PvP003 600 mg Multiple Dose |
|
At Day 14 and Day 28 |
|