A Phase 1 interventional study of PP-001 and Placebo in Keratoconjunctivitis and Ocular Surface Disease, sponsored by Panoptes Pharma GmbH. Completed at 1 site in Austria. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-12.
Sponsored by Panoptes Pharma GmbH · Phase 1, Interventional, and Treatment
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.
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.
27 studies on the registry are indexed under Keratoconjunctivitis; 3 are open to participants now.
This study's enrollment of 45 is close to the median of 45 across 19 interventional studies indexed under Keratoconjunctivitis.
Browse Keratoconjunctivitis studies →Panoptes Pharma GmbH is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Cohorts 1-3:
Cohort 4:
Exclusion Criteria (excerpt):
Cohorts 1-4:
PP-001 verum - cohort 1
Drug: PP-001
Placebo - cohort 1
Other: Placebo
PP-001 verum - cohort 2
Drug: PP-001
Placebo - cohort 2
Other: Placebo
PP-001 verum - cohort 3
Drug: PP-001
Placebo - cohort 3
Other: Placebo
PP-001 verum - cohort 4
Drug: PP-001
Placebo - cohort 4
Other: Placebo
PP-001 eye drops
Placebo eye drops
Evaluation of safety and tolerability by determining treatment emergent adverse events
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
Time frame: 28 days (cohorts 1-3) and 20 days (cohort 4)
Evaluation of Peak Plasma Concentration (Cmax) in peripheral blood
To evaluate the pharmacokinetics (Cmax) of PP-001 in healthy, adult volunteers following single and multiple daily ocular instillation
Time frame: 1 and 12 days (cohorts 1-3)
Evaluation of area under the plasma concentration versus time curve (AUC) in peripheral blood
To evaluate the pharmacokinetics (AUC) of PP-001 in healthy, adult volunteers following single and multiple daily ocular instillation
Time frame: 1 and 12 days (cohorts 1-3)
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Nov 2018 to primary completion in Sep 2021, 33 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Panoptes Pharma GmbH