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

Allergan

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: AGN-223575 Formulation B; Drug: AGN-223575 Formulation A; Drug: AGN-223575 Formulation C; Drug: AGN-223575 Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT02155543

223575-001

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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51 participants in 7 patient groups, including a placebo group

Cohort 1: AGN-223575 Form A/Vehicle

Experimental group

Description:

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.

Treatment:

Drug: AGN-223575 Vehicle

Drug: AGN-223575 Formulation A

Cohort 2: AGN-223575 Formulation A BID

Experimental group

Description:

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.

Treatment:

Drug: AGN-223575 Formulation A

Cohort 3: AGN-223575 Formulation B BID

Experimental group

Description:

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.

Treatment:

Drug: AGN-223575 Formulation B

Cohort 4: AGN-223575 Formulation C BID

Experimental group

Description:

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.

Treatment:

Drug: AGN-223575 Formulation C

AGN-223575 Vehicle BID

Placebo Comparator group

Description:

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.

Treatment:

Drug: AGN-223575 Vehicle

Cohort 5: AGN-223575 Formulation C TID

Experimental group

Description:

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.

Treatment:

Drug: AGN-223575 Formulation C

AGN-223575 Vehicle TID

Placebo Comparator group

Description:

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.

Treatment:

Drug: AGN-223575 Vehicle