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

NCT ID: NCT04759339

Last Updated: 2022-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-24
• Study Completion Date: 2021-02-25

Brief 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.

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).

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

AG-920

Intervention Type: DRUG

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

Interventions

AG-920

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

Intervention Type: DRUG

Other Intervention Names

Articaine Sterile Topical Ophthalmic Solution

Eligibility Criteria

Inclusion Criteria

1. Voluntarily provide written informed consent prior to any study-related procedures being performed.

2. Female subjects of childbearing potential must have negative pregnancy test.

3. Certified as healthy by clinical assessment.

4. Have an Early Treatment of Diabetic Retinopathy Study best corrected visual acuity of 20/200 or better in each eye.

5. Have an Intraocular Pressure between 7 and 30 mmHg inclusive.

6. Are able to tolerate instillation of Over-The-Counter artificial tear product .

7. Blood pressure < 140/90 mmHg and heart rate < 100 bpm at screening.

Exclusion Criteria

1. Have previously received AG-920.

2. Have a contraindication to local anesthetics.

3. Have had ocular surgery or general surgery within the past 90 days.

4. Have had an intravitreal injection in either eye within 14 days of treatment.

5. Have a history within the last year of or current ocular surface disease or nasolacrimal duct abnormalities including obstructions or requiring punctal plugs.

6. Have evidence of any current ocular inflammation.

7. Have a known current condition which could cause vision problems.

8. Current ocular allergy symptoms.

9. Have donated or lost more than 400 mL of blood within 12 weeks.

10. Plasma donation within 7 days prior to the first dosing.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

American Genomics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Uram, MD

Role: STUDY_DIRECTOR

American Genomics, LLC

Locations

Celerion

Lincoln, Nebraska, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35852839 (View on PubMed)

Other Identifiers

AG-920-CS101

Identifier Type: -

Identifier Source: org_study_id