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An Open Label, Study of the Systemic Exposure to Articaine After Topical Ocular Dosing of AG-920

NCT04759339 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-04-29

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

AG-920

AG-920 is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%

Sponsors & Collaborators

  • American Genomics, LLC

    lead INDUSTRY

Principal Investigators

  • Martin Uram, MD · American Genomics, LLC

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-24
Primary Completion
2021-02-25
Completion
2021-02-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04759339 on ClinicalTrials.gov