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This is a Phase 1, open-label, non-comparative study in healthy subjects performed in the US. It is designed to assess systemic exposure to articaine and its metabolite articainic acid after dosing a single topical ocular administration of AG-920 in the randomized study eye.
This is a Phase 1, open-label, non-comparative study in healthy subjects designed to assess systemic exposure to articaine and its metabolite articainic acid after dosing a single topical ocular administration of AG-920 in the randomized study eye.
In this study, subjects who provide informed consent and fulfill all the inclusion criteria and none of the exclusion criteria will receive a single dose of study drug in one eye. The study eye will be randomized. The single dose will be administered by the clinic staff as two drops 30 seconds apart in study eye. Subjects will have pharmacokinetic (PK) blood samples taken at multiple periods over 24 hours following dosing. Safety will be assessed by monitoring any changes in heart rate, blood pressure, intraocular pressure, visual acuity, biomicroscopy, and AEs.
The study will consist of 3 clinical visits: Screening Visit, Dosing and PK Blood Level Sampling (0-8 hours) Visit and a Follow Up Visit (with PK blood level sampling 24 hours after study drug treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AG-920 | Experimental | Subjects will receive a single dose of articaine sterile topical ophthalmic solution in one eye only. The study eye will be randomized. The single dose will be administered by the clinic staff as two drops in study eye 30 seconds apart. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AG-920 | Drug | AG-920 is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8% |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systemic exposure to articaine and its metabolite after dosing a single topical ocular administration of AG-920 | Plasma levels of articaine and its primary metabolite (articainic acid) | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment Emergent Adverse Events (TEAE) | TEAEs will be summarized by system organ class (SOC) and preferred term. | randomization through follow up (2 days) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Uram, MD | American Genomics, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35852839 | Derived | Verhoeven R, Uram M, Schupp A, Rasmussen S, Widmann M, Novack GD. Early Nonclinical and Clinical Development of AG-920, a Repurposed Topical Ocular Anesthetic. J Ocul Pharmacol Ther. 2022 Sep;38(7):481-488. doi: 10.1089/jop.2022.0026. Epub 2022 Jul 18. |
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An open label, non-comparative study of the systemic exposure to articaine after topical ocular dosing of articaine sterile topical ophthalmic solution
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