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

Ocular Surface Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769454
• Other study ID #: PP-001-1101
• Status: Completed
• Phase: Phase 1
• Start date: November 20, 2018
• Est. completion date: March 15, 2022

Study information

• Verified date: January 2024
• Source: Panoptes Pharma GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 15, 2022
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Keratoconjunctivitis
• Ocular Surface Disease

Intervention

Drug:
• PP-001
PP-001 eye drops

Other:
• Placebo
Placebo eye drops

Locations

Country	Name	City	State
Austria	University Hospital Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Panoptes Pharma GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days (cohorts 1-3) and 20 days (cohort 4)
Secondary	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	1 and 12 days (cohorts 1-3)
Secondary	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	1 and 12 days (cohorts 1-3)