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 being studied in healthy volunteers. It is not approved for any disease and is in clinical development to evaluate its safety, tolerability, and pharmacokinetics. The drug is being developed by AbbVie Inc. and has completed a Phase 1 trial.
The molecular target of AGN-223575 Formulation A has not been disclosed. It is a small molecule in Phase 1 clinical development for healthy volunteers, studied for safety, tolerability, and pharmacokinetics. No specific target or mechanism of action has been publicly reported.
AGN-223575 Formulation A is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is an investigational small molecule currently in Phase 1 clinical development.
AGN-223575 Formulation A is in Phase 1 clinical development. It is an investigational drug, not approved by regulatory authorities. A Phase 1 trial has been completed, and the drug is not yet available for clinical use.
AGN-223575 Formulation A has one completed clinical trial, NCT02155543, titled "A Safety, Tolerability, and Pharmacokinetics (PK) Study of AGN-223575 in Healthy Subjects." This Phase 1, randomized, double-blind, placebo-controlled study enrolled 51 participants in the United States.