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AGN-232411

Phase 1

Healthy Volunteers | Small molecule | Ophthalmology |AbbVie Inc.|Last Updated: Jul 14, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment77

FDA Designations

No designations recorded

Clinical trial landscape

AGN-232411 · 1 trial · 2 indications

Phase 1 1
NCT02420730Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry EyeHealthy Volunteers
COMPLETED77 Analytics
PHASE1COMPLETED
Safety, Tolerability and Systemic Pharmacokinetics of AGN-232411 in Healthy Participants and Participants With Dry Eye
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Study Endpoints

Primary Endpoints

Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Up to 56 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1A: AGN-232411 Dose AEXPERIMENTALOne 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 BEXPERIMENTALOne 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 CEXPERIMENTALOne 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 VehiclePLACEBO_COMPARATOROne 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 AEXPERIMENTALOne 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 BEXPERIMENTALOne 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 CEXPERIMENTALOne 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 VehiclePLACEBO_COMPARATOROne 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.

Interventions

NameTypeDescription
AGN-232411DRUGAGN-232411 topical ophthalmic solution
AGN-232411 VehicleDRUGVehicle for AGN-232411 topical ophthalmic solution.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites3

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, ...

Countries:United States
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Frequently asked questions about AGN-232411

What is AGN-232411 used for?

AGN-232411 is an investigational small molecule being developed by AbbVie Inc. for use in ophthalmology. It is being studied in healthy volunteers and in participants with dry eye syndromes, as part of a Phase 1 clinical trial.

Who makes AGN-232411?

AGN-232411 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol ABBV.

What phase is AGN-232411 in?

AGN-232411 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed.

What clinical trials is AGN-232411 in?

AGN-232411 has been studied in one completed Phase 1 trial, identified as NCT02420730. This trial evaluated the safety, tolerability, and systemic pharmacokinetics of AGN-232411 in healthy participants and participants with dry eye.

Is AGN-232411 the same as any other drug?

No alternative names for AGN-232411 have been disclosed. It is identified solely by its code name AGN-232411 in clinical trial records.