Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AGN-223575 Formulation A · 1 trial · 1 indication
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
AGN-223575 Formulation A is an investigational small molecule developed by AbbVie Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers, evaluating safety, tolerability, and pharmacokinetics. The specific therapeutic indication for this formulation has not been disclosed.
AGN-223575 Formulation A is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie sponsored the Phase 1 study of this small molecule formulation in healthy volunteers.
AGN-223575 Formulation A is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational agent and has not been approved by the FDA for any indication.
AGN-223575 Formulation A was evaluated in a single Phase 1 trial, NCT02155543, titled a safety, tolerability, and pharmacokinetics study in healthy subjects. The trial enrolled 51 participants in the United States, was randomized, double-blind, and placebo-controlled, and has been completed.
The Phase 1 trial NCT02155543 assessed the safety, tolerability, and pharmacokinetics of AGN-223575 Formulation A in healthy adult volunteers. It enrolled 51 participants of all sexes, aged 18 years and older, in the United States. The study was randomized, double-blind, and placebo-controlled.