NCT03769454

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Panoptes Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed description

In this prospective, single-centre, double blind (within each cohort), placebo controlled, randomised study, safety and tolerability of PP-001 eye drops is assessed in healthy, adult volunteers (cohorts 1-3) and in patients with ocular surface inflammation (cohort 4). PP-001 is a novel small molecule inhibitor of Dihydroorotate Dehydrogenase (DHODH) with anti-inflammatory properties.

Conditions

• Keratoconjunctivitis
• Ocular Surface Disease

Interventions

Type	Name	Description
DRUG	PP-001	PP-001 eye drops
OTHER	Placebo	Placebo eye drops

Timeline

• Start date: 2018-11-20
• Primary completion: 2021-09-15
• Completion: 2022-03-15
• First posted: 2018-12-07
• Last updated: 2024-01-12

Locations

1 site across 1 country: Austria