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

Panoptes Pharma

Status and phase: Completed; Phase 1

Conditions: Keratoconjunctivitis; Ocular Surface Disease

Treatments: Drug: PP-001; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03769454

PP-001-1101

Details and patient eligibility

About

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 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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 8 patient groups, including a placebo group

PP-001 verum - cohort 1

Experimental group

Description:

PP-001 verum - cohort 1

Treatment:

Drug: PP-001

Placebo - cohort 1

Placebo Comparator group

Description:

Placebo - cohort 1

Treatment:

Other: Placebo

PP-001 verum - cohort 2

Experimental group

Description:

PP-001 verum - cohort 2

Treatment:

Drug: PP-001

Placebo - cohort 2

Placebo Comparator group

Description:

Placebo - cohort 2

Treatment:

Other: Placebo

PP-001 verum - cohort 3

Experimental group

Description:

PP-001 verum - cohort 3

Treatment:

Drug: PP-001

Placebo - cohort 3

Placebo Comparator group

Description:

Placebo - cohort 3

Treatment:

Other: Placebo

PP-001 verum - cohort 4

Experimental group

Description:

PP-001 verum - cohort 4

Treatment:

Drug: PP-001

Placebo - cohort 4

Placebo Comparator group

Description:

Placebo - cohort 4

Treatment:

Other: Placebo