Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02155543 | A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects | PHASE1 | COMPLETED | 51 | — | — | May 1, 2014 | Jan 1, 2015 | Apr 12, 2016 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: AGN-223575 Form A/Vehicle | EXPERIMENTAL | 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. |
| Cohort 2: AGN-223575 Formulation A BID | EXPERIMENTAL | 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. |
| Cohort 3: AGN-223575 Formulation B BID | EXPERIMENTAL | 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. |
| Cohort 4: AGN-223575 Formulation C BID | EXPERIMENTAL | 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. |
| AGN-223575 Vehicle BID | PLACEBO_COMPARATOR | 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. |
| Cohort 5: AGN-223575 Formulation C TID | EXPERIMENTAL | 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. |
| AGN-223575 Vehicle TID | PLACEBO_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| AGN-223575 Formulation A | DRUG | One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol. |
| AGN-223575 Formulation B | DRUG | 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. |
| AGN-223575 Formulation C | DRUG | 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. |
| AGN-223575 Vehicle | DRUG | One drop of AGN-223575 vehicle administered in the study eye(s) per protocol. |
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