- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04759339
An Open Label, Study of the Systemic Exposure to Articaine After Topical Ocular Dosing of AG-920
An Open Label, Non-Comparative Study of the Systemic Exposure to Articaine After Topical Ocular Dosing of Articaine Sterile Topical Ophthalmic Solution (AG-920)
Study Overview
Detailed Description
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).
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Nebraska
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Lincoln, Nebraska, United States, 68502
- Celerion
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Key Inclusion Criteria:
- Voluntarily provide written informed consent prior to any study-related procedures being performed.
- Female subjects of childbearing potential must have negative pregnancy test.
- Certified as healthy by clinical assessment.
- Have an Early Treatment of Diabetic Retinopathy Study best corrected visual acuity of 20/200 or better in each eye.
- Have an Intraocular Pressure between 7 and 30 mmHg inclusive.
- Are able to tolerate instillation of Over-The-Counter artificial tear product .
- Blood pressure < 140/90 mmHg and heart rate < 100 bpm at screening.
Key Exclusion Criteria:
- Have previously received AG-920.
- Have a contraindication to local anesthetics.
- Have had ocular surgery or general surgery within the past 90 days.
- Have had an intravitreal injection in either eye within 14 days of treatment.
- Have a history within the last year of or current ocular surface disease or nasolacrimal duct abnormalities including obstructions or requiring punctal plugs.
- Have evidence of any current ocular inflammation.
- Have a known current condition which could cause vision problems.
- Current ocular allergy symptoms.
- Have donated or lost more than 400 mL of blood within 12 weeks.
- Plasma donation within 7 days prior to the first dosing.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AG-920
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.
|
AG-920 is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systemic exposure to articaine and its metabolite after dosing a single topical ocular administration of AG-920
Time Frame: 8 hours
|
Plasma levels of articaine and its primary metabolite (articainic acid)
|
8 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Time Frame: randomization through follow up (2 days)
|
TEAEs will be summarized by system organ class (SOC) and preferred term.
|
randomization through follow up (2 days)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Martin Uram, MD, American Genomics, LLC
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AG-920-CS101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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