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

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ClinicalTrials.gov Identifier: NCT03769454
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Panoptes Pharma GmbH

Brief 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).

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis Drug: PP-001 Other: Placebo Phase 1

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. PP-001 is a novel small molecule inhibitor of Dihydroorotate Dehydrogenase (DHODH) with anti-inflammatory properties. PP-001 eye drops will be administered up to 4 times per day over a period of 13 days in ascending doses. Participants will be monitored for safety and tolerability evaluation of the study drug.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase I Safety and Tolerability Study of PP-001 Eye Drops in Healthy Adult Volunteers
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : May 31, 2019

Arm Intervention/treatment
Experimental: PP-001 low dose group Drug: PP-001
PP-001 eye drops

Placebo Comparator: Placebo low dose group Other: Placebo
Placebo eye drops

Experimental: PP-001 mid dose group Drug: PP-001
PP-001 eye drops

Placebo Comparator: Placebo mid dose group Other: Placebo
Placebo eye drops

Experimental: PP-001 high dose group Drug: PP-001
PP-001 eye drops

Placebo Comparator: Placebo high dose group Other: Placebo
Placebo eye drops




Primary Outcome Measures :
  1. Evaluation of safety and tolerability by determining treatment emergent adverse events [ Time Frame: 28 days ]
    To assess safety and tolerability of ascending, multiple daily doses of PP-001 eye drops in healthy, adult volunteers


Secondary Outcome Measures :
  1. Evaluation of Peak Plasma Concentration (Cmax) in peripheral blood [ Time Frame: 1 and 12 days ]
    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 ]
    To evaluate the pharmacokinetics (AUC) of PP-001 in healthy, adult volunteers following single and multiple daily ocular instillation



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769454


Contacts
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Contact: Panoptes Study Director info@panoptes-pharma.com

Locations
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Austria
University Hospital Vienna Recruiting
Vienna, Austria
Contact: Panoptes Study Director       info@panoptes-pharma.com   
Sponsors and Collaborators
Panoptes Pharma GmbH

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Responsible Party: Panoptes Pharma GmbH
ClinicalTrials.gov Identifier: NCT03769454     History of Changes
Other Study ID Numbers: PP-001-1101
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Ophthalmic Solutions
Pharmaceutical Solutions