Clinical trial

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

Name

PP-001-1101

Description

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.

Trial arms

Trial start

2018-11-20

Estimated PCD

2021-09-15

Trial end

2022-03-15

Status

Completed

Phase

Early phase I

Treatment

PP-001

PP-001 eye drops

Arms:

PP-001 verum - cohort 1, PP-001 verum - cohort 2, PP-001 verum - cohort 3, PP-001 verum - cohort 4

Placebo

Placebo eye drops

Arms:

Placebo - cohort 1, Placebo - cohort 2, Placebo - cohort 3, Placebo - cohort 4

Size

Primary endpoint

Evaluation of safety and tolerability by determining treatment emergent adverse events

28 days (cohorts 1-3) and 20 days (cohort 4)

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ACTUAL'}}

Updated at

2024-01-12

1 organization

1 product

2 indications

Product

PP-001

Indication

Keratoconjunctivitis

Indication

Ocular Surface Disease

Organization

Panoptes Pharma