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

NCT02155543 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2016-04-12

Study results available
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Summary

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

Conditions

  • Healthy Volunteers

Interventions

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.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02155543 on ClinicalTrials.gov