Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PPI-383 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| PPI-383 single dose escalation in healthy volunteers | EXPERIMENTAL | There will be up to 10 sequential single dose cohorts to assess the bioavailability of different doses and formulations; a food effect cohort will be included. |
| PPI-383 multiple doses in healthy volunteers | EXPERIMENTAL | Upon completion of the single dose cohorts, an additional cohort will receive the highest well-tolerated dose from the single dose cohorts or placebo once daily for five days; up to additional cohorts may receive multiple doses of different formulations or different regimens |
| PPI-383 multiple dose escalation in HCV Subjects | EXPERIMENTAL | Upon completion of the single and multiple dose healthy volunteer cohorts, there will be 3, and potentially 4, sequential cohorts of HCV patients |
| Name | Type | Description |
|---|---|---|
| PPI-383 | DRUG | - |
| Placebo | DRUG | - |
Part I volunteers (single and multiple dose) - key inclusion criteria * Healthy males * Age 18 to 55 years * Body mass index (BMI)18 to 32 kg/m2 Part II patients- key inclusion criteria * Males, or females of non-childbearing potential * Age 18 to 65 years * Chronic hepatitis C, and absence of ot...
PPI-383 is an investigational small molecule being developed for the treatment of chronic hepatitis C. It is currently in Phase 1 clinical development and has been studied in a completed trial that included healthy adults and patients with chronic hepatitis C.
The specific molecular target of PPI-383 has not been disclosed. It is a small molecule being investigated for chronic hepatitis C, but its mechanism of action is not publicly detailed.
PPI-383 is being developed by BioCryst Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol BCRX.
PPI-383 is in Phase 1 clinical development. It has completed a Phase 1a/1b study, and no active trials are currently listed for this drug.
PPI-383 has been studied in a completed Phase 1 clinical trial with the identifier NCT01928147. This trial enrolled 114 participants, including healthy volunteers and patients with chronic hepatitis C, and was conducted in Mauritius and the United Kingdom.
PPI-383 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials, but it has not yet received regulatory approval for any indication.