A Phase I Study of PP-001 Eye Drops in Healthy Adult Volunteers
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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).
Condition or disease
Drug: PP-001Other: Placebo
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. PP-001 is a novel small molecule inhibitor of Dihydroorotate Dehydrogenase (DHODH) with anti-inflammatory properties. PP-001 eye drops will be administered up to 4 times per day over a period of 13 days in ascending doses. Participants will be monitored for safety and tolerability evaluation of the study drug.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 64 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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