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Adjusted LOA
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AGN-232411 · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Cohort 1A: AGN-232411 Dose A | EXPERIMENTAL | One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants. |
| Cohort 1B: AGN-232411 Dose B | EXPERIMENTAL | One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose A in Cohort 1A is acceptable. |
| Cohort 1C: AGN-232411 Dose C | EXPERIMENTAL | One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants if the safety and tolerability of Dose B in Cohort 1B is acceptable. |
| Cohort 1: AGN-232411 Vehicle | PLACEBO_COMPARATOR | One drop of Vehicle for AGN-232411 topical ophthalmic solution administered in the study eye once daily for one day, followed by twice daily for 16 days in healthy participants. |
| Cohort 2A: AGN-232411 Dose A | EXPERIMENTAL | One drop of AGN-232411 topical ophthalmic solution Dose A administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease. |
| Cohort 2B: AGN-232411 Dose B | EXPERIMENTAL | One drop of AGN-232411 topical ophthalmic solution Dose B administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose A in Cohort 2A is acceptable. |
| Cohort 2C: AGN-232411 Dose C | EXPERIMENTAL | One drop of AGN-232411 topical ophthalmic solution Dose C administered in the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease if the safety and tolerability of Dose B in Cohort 2B is acceptable. |
| Cohort 2: AGN-232411 Vehicle | PLACEBO_COMPARATOR | One drop of Vehicle for AGN-232411 topical ophthalmic solution administered to the study eye once daily for one day, followed by twice daily for 27 days in participants with dry eye disease. |
| Name | Type | Description |
|---|---|---|
| AGN-232411 | DRUG | AGN-232411 topical ophthalmic solution |
| AGN-232411 Vehicle | DRUG | Vehicle for AGN-232411 topical ophthalmic solution. |
Inclusion criteria: Stage 1 -Healthy participants. Stage 2 -Participants with the symptoms of dry eye disease. Exclusion criteria: Stage 1 -Known allergies or sensitivities to study medications, fluorescein, or lissamine green Stage 2 * Known allergies or sensitivities to study medications, ...
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AGN-232411 is an investigational small molecule being developed by AbbVie Inc. for dry eye syndromes. It is in Phase 1 clinical development and has been studied in a single completed trial. It is not an approved therapy.
AGN-232411 is being studied for dry eye syndromes, an ophthalmology condition. The only completed trial enrolled healthy participants and participants with dry eye to evaluate safety, tolerability and systemic pharmacokinetics. No approved use has been established for AGN-232411.
AGN-232411 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor behind the compound's clinical program in ophthalmology.
AGN-232411 is in Phase 1 clinical development. It is an investigational small molecule and has not been approved for any indication. One Phase 1 trial has been completed, and no trials are currently listed as active.
AGN-232411 has been evaluated in one completed Phase 1 trial, NCT02420730, titled Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye. The trial enrolled 77 participants in the United States, was randomized, double blind and placebo controlled.
The Phase 1 trial of AGN-232411, NCT02420730, enrolled 77 participants. It included healthy volunteers and participants with dry eye, accepted participants aged 18 years and older of any sex, and was conducted in the United States.