HealthyPhase 1NCT04759339
An Open Label, Study of the Systemic Exposure to Articaine After Topical Ocular Dosing of AG-920
A Phase 1 study testing AG-920 in people with Healthy, run by American Genomics, LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AG-920
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2021to 25 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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
- Being tested
- AG-920
- Keywords
- articaine, AG-920
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-920Drug
Also called Articaine Sterile Topical Ophthalmic Solution
AG-920 is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: AG-920 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 8 hours
Secondary outcomes (1)
Number of Participants with Treatment Emergent Adverse Events (TEAE)
TEAEs will be summarized by system organ class (SOC) and preferred term.
Measured: randomization through follow up (2 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start24 Feb 2021
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- An open label, non-comparative study of the systemic exposure to articaine after topical ocular dosing of articaine sterile topical ophthalmic solution
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Genomics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Uram, MD, Study director, American Genomics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759339
- Sponsor's protocol ID
- AG-920-CS101
- Status last verified
- Apr 2022
- First submitted
- 15 Feb 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35852839
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04759339
- Acronym / sponsor ID
- AG-920-CS101
- Conditions
- Healthy
- Keywords
- articaine, AG-920
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- American Genomics, LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- An open label, non-comparative study of the systemic exposure to articaine after topical ocular dosing of articaine sterile topical ophthalmic solution
| Arm | Type | Receives |
|---|---|---|
| AG-920 | Experimental | Drug: AG-920Subjects 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AG-920Also: Articaine Sterile Topical Ophthalmic SolutionAG-920 is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8% | Drug | AG-920 |
Primary outcome
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)
1 secondary outcome
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Time frame: randomization through follow up (2 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Derived from this study: PubMed 35852839Verhoeven 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Uram, MD study director
American Genomics, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AG-920 in people with Healthy, run by American Genomics, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic exposure to articaine and its metabolite after dosing a single topical ocular administration of AG-920 (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04759339, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.