Keratoconjunctivitis, Ocular Surface Disease
Conditions
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 (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.
Interventions
DRUGPP-001
PP-001 eye drops
OTHERPlacebo
Placebo eye drops
Sponsors
Panoptes Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of safety and tolerability by determining treatment emergent adverse events | 28 days (cohorts 1-3) and 20 days (cohort 4) | To assess safety and tolerability of ascending, multiple daily doses of PP-001 eye drops in healthy, adult volunteers and in patients with ocular surface inflammation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Peak Plasma Concentration (Cmax) in peripheral blood | 1 and 12 days (cohorts 1-3) | To evaluate the pharmacokinetics (Cmax) of PP-001 in healthy, adult volunteers following single and multiple daily ocular instillation |
| Evaluation of area under the plasma concentration versus time curve (AUC) in peripheral blood | 1 and 12 days (cohorts 1-3) | To evaluate the pharmacokinetics (AUC) of PP-001 in healthy, adult volunteers following single and multiple daily ocular instillation |
Countries
Austria
Outcome results
None listed