Clinical trial NCT04759339: An Open Label, Study of the Systemic Exposure to Articaine After Topical Ocular Dosing of AG-920
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: articaine
AG-920
Lead sponsor: American Genomics, LLC
Sponsor class: INDUSTRY
First posted: 2021-02-18
Enrollment: 14
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: An open label, non-comparative study of the systemic exposure to articaine after topical ocular dosing of articaine sterile topical ophthalmic solution
Primary purpose: BASIC_SCIENCE

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).

Eligibility criteria: Key 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.

Key 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.

Primary outcomes:
measure: Systemic exposure to articaine and its metabolite after dosing a single topical ocular administration of AG-920
timeFrame: 8 hours
Secondary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events (TEAE)
timeFrame: randomization through follow up (2 days)
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: American Genomics, LLC
name: Martin Uram, MD
role: STUDY_DIRECTOR
References:
citation: 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.