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

Overview

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.

Full Title of Study: “A Phase I Safety and Tolerability Study of PP-001 Eye Drops in Healthy Adult Volunteers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: September 15, 2021

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

  • Drug: PP-001
    • PP-001 eye drops
  • Other: Placebo
    • Placebo eye drops

Arms, Groups and Cohorts

  • Experimental: PP-001 verum – cohort 1
    • PP-001 verum – cohort 1
  • Placebo Comparator: Placebo – cohort 1
    • Placebo – cohort 1
  • Experimental: PP-001 verum – cohort 2
    • PP-001 verum – cohort 2
  • Placebo Comparator: Placebo – cohort 2
    • Placebo – cohort 2
  • Experimental: PP-001 verum – cohort 3
    • PP-001 verum – cohort 3
  • Placebo Comparator: Placebo – cohort 3
    • Placebo – cohort 3
  • Experimental: PP-001 verum – cohort 4
    • PP-001 verum – cohort 4
  • Placebo Comparator: Placebo – cohort 4
    • Placebo – cohort 4

Clinical Trial Outcome Measures

Primary Measures

  • Evaluation of safety and tolerability by determining treatment emergent adverse events
    • Time Frame: 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 Measures

  • Evaluation of Peak Plasma Concentration (Cmax) in peripheral blood
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Panoptes Pharma GmbH
  • Provider of Information About this Clinical Study
    • Sponsor

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