NCT02155543

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Allergan · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	AGN-223575 Formulation A	One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.
DRUG	AGN-223575 Formulation B	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 C	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 Vehicle	One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.

Timeline

• Start date: 2014-05-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2014-06-04
• Last updated: 2016-04-12
• Results posted: 2016-04-12

Locations

1 site across 1 country: United States