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Completed

NCT Number: NCT03769454

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

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.

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Key information

Conditions

Keratoconjunctivitis Conjunctival Diseases Conjunctivitis Corneal Diseases Eye Diseases Keratitis Ocular Surface Disease

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Vienna

Vienna, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PP-001

Drug

PP-001 eye drops

Placebo

Other

Placebo eye drops

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Panoptes Pharma GmbH

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Dec 7, 2018
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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