Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PvP001 · 1 trial · 1 indication
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Part 1, Cohort 1A-1 to 1D-1 Healthy Participants | EXPERIMENTAL | A single dose of PvP001 placebo, PvP001 100 mg, PvP001 300 mg, or PvP001 900 mg will be administered in ascending order to healthy participants in Cohorts 1A-1, 1B-1, 1C-1, and 1D-1. |
| Part 1, Cohort 1E-1 Healthy Participants | EXPERIMENTAL | A single dose of the maximum feasible dose (MFD) of PvP002 will then be administered to healthy participants in Cohort 1E-1. |
| Part 1, Cohort 1A-2 - 1D-2 Celiac Disease (CeD) | EXPERIMENTAL | A single dose of PvP001 placebo, PvP001 100 mg, PvP001 300 mg, or PvP001 900 mg will be administered in ascending order to participants with CeD in Cohorts 1A-2, 1B-2, 1C-2, and 1D-2. |
| Part 1, Cohort 1E-2 CeD | EXPERIMENTAL | A single dose of the MFD of PvP002 will then be administered to participants with CeD in Cohort 1E-2. |
| Part 2, Cohort 2A - Cohort 2C Healthy Participants | EXPERIMENTAL | Participants will be blinded to the PvP001 dose (placebo or MTD of PvP001) and will also receive MTD of PvP001 following 7 days of PPI treatment. |
| Part 2, Cohort 2D Healthy Participants | EXPERIMENTAL | Participants will receive PvP001 placebo or MFD of PvP001. |
| Part 2, Cohort 2E Healthy Participants | EXPERIMENTAL | Participants will receive PvP002 placebo or MFD of PvP002. |
| Part 2, Cohort 2F- Cohort 2H Healthy Participants | EXPERIMENTAL | Participants will receive the PvP001 placebo and either 300 mg or 600 mg of PvP001. |
| Part 2, Cohort 2I and Cohort 2J Healthy Participants | EXPERIMENTAL | Participants will receive the PvP001 placebo and 900 mg of PvP001. |
| Part 3, Cohorts 3A and 3B Healthy Participants | EXPERIMENTAL | Participants will receive single dose of PvP003 placebo and 600 mg of PvP003 with pretreatment buffer solution before a standardized 1 gm gluten-containing study meal. |
| Part 3, Cohorts 3C and 3D Healthy Participants | EXPERIMENTAL | Participants will receive single dose of PvP003 placebo and 600 mg of PvP003 without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal. |
| Part 3, Cohorts 3E and 3F Healthy Participants | EXPERIMENTAL | Participants will receive single dose of PvP003 placebo and 600 mg of PvP003 without pretreatment buffer solution after an approximately 50 milliliter (mL) portion of a standardized 1 gm gluten-containing study meal. |
| Part 3, Cohorts 3G and 3H Healthy Participants | EXPERIMENTAL | Participants will receive single dose of PvP003 placebo and 600 mg of PvP003 without pretreatment buffer solution before a standardized gluten-free study meal followed approximately 30 minutes later by a standardized 1 gm gluten-containing study meal. |
| Part 4, Cohorts 4A and 4B Healthy Participants | EXPERIMENTAL | Participants will receive multiple dose of PvP003 placebo and 600 mg of PvP003. |
| Part 3, Cohorts 3I and 3J Healthy Participants | EXPERIMENTAL | Participants will receive single dose of PvP003 placebo and 150 mg of PvP003 without pretreatment buffer solution before a standardized 1 gm gluten-containing study meal. |
| Name | Type | Description |
|---|---|---|
| PvP001 placebo | OTHER | placebo |
| PvP001 100 mg | DRUG | PvP001 100 mg |
| PvP001 300 mg | DRUG | PvP001 300 mg |
| PvP001 900 mg | DRUG | PvP001 900 mg |
| Maximum Feasible Dose (MFD) of PvP002 | DRUG | MFD of PvP002 |
| Maximum Tolerated Dose (MTD) of PvP001 | DRUG | Maximum Tolerated Dose (MTD) of PvP001 |
| MTD of PvP001 following 7 days of PPI treatment | DRUG | Maximum Tolerated Dose (MTD) of PvP001 following 7 days of PPI (Proton Pump Inhibitor) treatment |
| PvP002 placebo | OTHER | Placebo |
| PvP001 600 mg | DRUG | PvP001 600 mg |
| PvP003 placebo | DRUG | Placebo tablet orally. |
| PvP003 | DRUG | PvP003 tablet orally. |
| PvP003 150 mg | DRUG | PvP003 150 mg |
Inclusion Criteria: Part 1, Part 2, Part 3 and Part 4 1. Male or female age 18- 64 years, inclusive 2. No relevant gastrointestinal symptoms 3. Able to abstain from alcohol for 72 hours prior to the Screening Visit; for 72 hours prior to and after the Cohort Treatment Day (Part 1, Part 2, and Part...
PvP001 is an investigational small molecule being studied for the treatment of digestive system disease, specifically in adults with celiac disease. It is currently in Phase 1 clinical development and has not been approved by the FDA.
PvP001 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
PvP001 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and potential efficacy.
PvP001 has been studied in a Phase 1 clinical trial with the identifier NCT03701555. This completed trial enrolled 139 participants and evaluated PvP001, along with PVP002 and PVP003, in healthy adults and adults with celiac disease.
No, PvP001 is a distinct investigational drug from PVP002 and PVP003. However, all three were studied together in a single Phase 1 clinical trial (NCT03701555) that evaluated their safety and tolerability in healthy adults and adults with celiac disease.