Status:
COMPLETED
A Phase I Study of PP-001 Eye Drops in Healthy Adult Volunteers
Lead Sponsor:
Panoptes Pharma GmbH
Conditions:
Keratoconjunctivitis
Ocular Surface Disease
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief 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 (Dihydroorota...
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 (cohor...
Eligibility Criteria
Inclusion
- Inclusion Criteria (excerpt):
- Cohorts 1-3:
- male or female healthy volunteers 18 - 64 years of age
- good general state of health and participants must not have a diagnosis of any eye disease that could effect the pharmacokinetics of PP-001
- Cohort 4:
- male or female subjects 18-64 years of age with ocular surface inflammation in both eyes
- ocular surface inflammation as defined per protocol
- good general state of health
- Exclusion Criteria (excerpt):
- Cohorts 1-4:
- participation in other clinical trials within 30 days prior to dosing start (ocular and non-ocular clinical trials)
- pregnant or nursing patients
- regular use of any ocular agents within 60 days prior to start dosing
Exclusion
Key Trial Info
Start Date :
November 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03769454
Start Date
November 20 2018
End Date
March 15 2022
Last Update
January 12 2024
Active Locations (1)
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1
University Hospital Vienna
Vienna, Austria