Back to resultsA Phase I Study of PP-001 Eye Drops in Healthy Adult Volunteers
Primary Purpose
Keratoconjunctivitis
Status
Unknown status
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
PP-001
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconjunctivitis
Eligibility 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
Sites / Locations
- University Hospital Vienna
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
PP-001 low dose group
Placebo low dose group
PP-001 mid dose group
Placebo mid dose group
PP-001 high dose group
Placebo high dose group
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03769454
Brief Title
A Phase I Study of PP-001 Eye Drops in Healthy Adult Volunteers
Official Title
A Phase I Safety and Tolerability Study of PP-001 Eye Drops in Healthy Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Panoptes Pharma GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PP-001 low dose group
Arm Type
Experimental
Arm Title
Placebo low dose group
Arm Type
Placebo Comparator
Arm Title
PP-001 mid dose group
Arm Type
Experimental
Arm Title
Placebo mid dose group
Arm Type
Placebo Comparator
Arm Title
PP-001 high dose group
Arm Type
Experimental
Arm Title
Placebo high dose group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PP-001
Intervention Description
PP-001 eye drops
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo eye drops
Primary Outcome Measure Information:
Title
Evaluation of safety and tolerability by determining treatment emergent adverse events
Description
To assess safety and tolerability of ascending, multiple daily doses of PP-001 eye drops in healthy, adult volunteers
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Evaluation of Peak Plasma Concentration (Cmax) in peripheral blood
Description
To evaluate the pharmacokinetics (Cmax) of PP-001 in healthy, adult volunteers following single and multiple daily ocular instillation
Time Frame
1 and 12 days
Title
Evaluation of area under the plasma concentration versus time curve (AUC) in peripheral blood
Description
To evaluate the pharmacokinetics (AUC) of PP-001 in healthy, adult volunteers following single and multiple daily ocular instillation
Time Frame
1 and 12 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
University Hospital Vienna
City
Vienna
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
A Phase I Study of PP-001 Eye Drops in Healthy Adult Volunteers
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