drugset / Trial / NCT03769454

A Phase I Study of PP-001 Eye Drops in Healthy Adult Volunteers

NCT03769454 ↗

Phase 1 Completed 45 enrolled Panoptes Pharma GmbH
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

EvaluationDrugModalityDoseRoute
Subject KIO-100 Small molecule — Topical

Indications