drugset / Trial / NCT03769454
A Phase I Study of PP-001 Eye Drops in Healthy Adult Volunteers
RandomizedParallel-groupTriple-blindTreatment
Summary
In this study, PP-001 eye drops are assessed for safety and tolerability in healthy, adult volunteers. PP-001 is a novel, anti-inflammatory small molecule that inhibits a specific enzyme (Dihydroorotate Dehydrogenase). The study was amended and now includes patients with ocular surface inflammation.
Timeline
- Start
- 2018-11-20
- Primary completion
- 2021-09-15
- Completion
- 2022-03-15
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
release “KIO-101 topically at multiple doses was well tolerated in healthy volunteers and patients with inflammation of the eye.” kiorapharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | KIO-100 | Small molecule | — | Topical |