A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects

Study Overview
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Brief Summary
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This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of AGN-223575 in healthy subjects.

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: AGN-223575 Formulation A
* Drug: AGN-223575 Formulation B
* Drug: AGN-223575 Formulation C
* Drug: AGN-223575 Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Weight at least 110 lbs Exclusion Criteria: Use of contact lenses within 14 days, or planned use during the study Use of any ocular eye medications within 30 days, or anticipated use during the study Anticipated use of any artificial tears product during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: AGN-223575 Form A/Vehicle<br>One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days. | Drug: AGN-223575 Formulation A<br>* One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.<br>Drug: AGN-223575 Vehicle<br>* One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.<br>|
| Experimental: Cohort 2: AGN-223575 Formulation A BID<br>One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15. | Drug: AGN-223575 Formulation A<br>* One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.<br>|
| Experimental: Cohort 3: AGN-223575 Formulation B BID<br>One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15. | Drug: AGN-223575 Formulation B<br>* One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.<br>|
| Experimental: Cohort 4: AGN-223575 Formulation C BID<br>One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15. | Drug: AGN-223575 Formulation C<br>* One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.<br>|
| Placebo Comparator: AGN-223575 Vehicle BID<br>One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15. | Drug: AGN-223575 Vehicle<br>* One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.<br>|
| Experimental: Cohort 5: AGN-223575 Formulation C TID<br>One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15. | Drug: AGN-223575 Formulation C<br>* One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.<br>|
| Placebo Comparator: AGN-223575 Vehicle TID<br>One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15. | Drug: AGN-223575 Vehicle<br>* One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Plasma Concentration (Cmax) of AGN-223575 | Concentrations of AGN-223575 were measured in the plasma (the liquid component of the blood in which the blood cells are suspended) in samples collected up to 24 hours post-dose. The Cmax is reported. | Day 15 |