Wet Age Related Macular DegenerationPhase 1NCT06969001
Clinical Study for the Evaluation of Safety and Tolerability of SCAI-005 Eye Drops
A Phase 1 study of Wet Age Related Macular Degeneration, run by SCAI Therapeutics at 1 site in South Korea.
Trial summary
To assess the single-dose and multiple-dose pharmacokinetics (PK), safety and tolerability of SCAI-005 eyedrops(axitinib) in healthy volunteers Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Wet Age Related Macular Degeneration
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 29 May 2025to 4 Sep 2025
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult subjects aged 19 to 50 years at the time of screening
- Male subjects with a body weight of 55.0 kg or more, Female subjects with a body weight of 50kg or more, and within ±20% of ideal body weight at the time of screening
- Subject who voluntarily agrees to participate in this study and has given a written informed consent, after fully understanding the detailed explanation of this study
Who cannot join
- Subjects with symptoms suggestive of an acute disease at the time of screening
- Subjects with clinically significant and active diseases related to cardiovascular system, gastrointestinal system, respiratory system, endocrine system, neuropsychiatric system, hematologic/oncologic system
- Subjects meeting any of the following criteria based on examination during screening:
- AST, ALT > 1.5 X ULN
- Total bilitubin > 1.5 X ULN
- eGFR (estimated Glomerular Filtration Rate) < 90 mL/min/1.73 m2
Show all 30Show fewer
- serological test result = positive
- Subjects with systolic blood pressure of 90 mmHg or less, or 150 mmHg or more, or diastolic blood pressure of 50 mmHg or less, or 100 mmHg or more after sitting for at least 5 minutes during screening (Visit 1)
- Subjects meeting any of the following criteria based on ophthalmological examination during screening:
- Best corrected visual acuity < 0.6
- IOP > 21 mmHg
- difference in IOP between both eyes > 4mmHg
- subjects who are assessed ineligible due to abnormal findings in other ophthalmonlogical examinations
- History or suspicion of conditions affecting visual organs such as keratitis, iritis, uveitis, retinitis, dry eye syndrome, strabismus within 12months prior to screening visit
- Ophthalmologic surgery within 12 months prior to screening visit
- Subjects with acute or chronic eye diseases requiring topical eyedrops at the time of screening
- Experience of adverse effects from contact lens use, or contact lens use within one month prior to screening visit, or inability to abstain from contact lens use during the clinical trial
- Subjects with a history of drug abuse or a positive result on a urine drug test at screening
- Subjects with a history of hypersensitivity to the investigational drug, or to drugs in the same class as the active ingredients
- Subjects who have participated in another clinical trial and received an investigational drug within 6 months prior to the anticipated first dose
- Subjects who have taken drug metabolism inducers or inhibitors, such as barbiturates, within one month prior to the expected first dosing date
- Subjects who have donated whole blood within 2 months, or component blood within 20 days
- Subjects who have taken any prescription drugs or oriental medicine within 2 weeks of the expected first dosing date, or any over-the-counter drugs or vitamins within 1 week of the expected first dosing date
- Subjects unable to restrict grapefruit or grapefruit-containing food consumption from 7 days prior to the anticipated first dose through the duration of the clinical trial.
- Subjects who regularly consume caffeine (e.g., coffee or green tea more than 5 units/day) or are unable to abstain from caffeine-containing foods from 24 hours prior to hospitalization to discharge
- Subjects who have consumed alcohol regularly (more than 210g/week) or are unable to abstain from alcohol from 24 hours prior to hospitalization to discharge
- Subjects who have regularly smoked (including e-cigarettes, more than 10 cigarettes/day) or are unable to abstain from 24 hours prior to hospitalization to discharge
- Female participants who are pregnant, or are breastfeeding
- Subjects who, during the entire clinical trial period and for at least 90 days after the last dose of the investigational drug, cannot or do not agree to use medically acceptable double contraception methods, or who do not agree to refrain from donating sperm during this period
- Subjects deemed unsuitable for participation by the investigator for other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site
The Catholic University, Seoul ST. Mary's Hospital
Seoul
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Administration of SCAI-005 Ophthalmic Solution in Healthy Korean Subjects
To assess the single-dose and multiple-dose pharmacokinetics (PK), safety and tolerability of SCAI-005 eyedrops(axitinib) in healthy volunteers
- Conditions
- Wet Age Related Macular Degeneration
- Being tested
- SCAI-005 0.04% or placebo, SCAI-005 0.08% or placebo, SCAI-005 0.08% or placebo 2drops
- Keywords
- axitinib, eyedrop, tyrosine kinase inhibitor, wetAMD, CNV, Phase1, SCAI-005
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCAI-005 0.04% or placeboDrug
axitinib 0.014mg or placebo
SCAI-005 0.08% or placeboDrug
axitinib 0.028mg or placebo
SCAI-005 0.08% or placebo 2dropsDrug
axitinib 0.056mg or placebo
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose | Experimental | Day 1: One time administration, 8 subjects randomized 3:1 to SCAI-005 or placebo in each cohort Receives: Drug: SCAI-005 0.04% or placebo; Drug: SCAI-005 0.08% or placebo; Drug: SCAI-005 0.08% or placebo 2drops |
| Multiple Ascending Dose | Experimental | Three times administration daily (TID) for 7days, 8 subjects randomized 3:1 to SCAI-005 or placebo in each cohort Receives: Drug: SCAI-005 0.04% or placebo; Drug: SCAI-005 0.08% or placebo; Drug: SCAI-005 0.08% or placebo 2drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation: Incidence, type, and severity of Adverse Events (AE)
Measured: 15days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start29 May 2025
- Primary completion4 Sep 2025
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet Age Related Macular DegenerationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- SCAI Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969001
- Sponsor's protocol ID
- SCAI-005-101
- Status last verified
- Sep 2025
- First submitted
- 28 Apr 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Administration of SCAI-005 Ophthalmic Solution in Healthy Korean Subjects
- ClinicalTrials.gov ID
- NCT06969001
- Acronym / sponsor ID
- SCAI-005-101
- Conditions
- Wet Age Related Macular Degeneration
- Keywords
- axitinib, eyedrop, tyrosine kinase inhibitor, wetAMD, CNV, Phase1, SCAI-005
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- SCAI TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 29 May 2025 (actual)
- Primary completion
- 4 Sep 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 13 May 2025 (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.
To assess the single-dose and multiple-dose pharmacokinetics (PK), safety and tolerability of SCAI-005 eyedrops(axitinib) in healthy volunteers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose | Experimental | Drug: SCAI-005 0.04% or placebo, Drug: SCAI-005 0.08% or placebo, Drug: SCAI-005 0.08% or placebo 2dropsDay 1: One time administration, 8 subjects randomized 3:1 to SCAI-005 or placebo in each cohort |
| Multiple Ascending Dose | Experimental | Drug: SCAI-005 0.04% or placebo, Drug: SCAI-005 0.08% or placebo, Drug: SCAI-005 0.08% or placebo 2dropsThree times administration daily (TID) for 7days, 8 subjects randomized 3:1 to SCAI-005 or placebo in each cohort |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adult subjects aged 19 to 50 years at the time of screening
- Male subjects with a body weight of 55.0 kg or more, Female subjects with a body weight of 50kg or more, and within ±20% of ideal body weight at the time of screening
- Subject who voluntarily agrees to participate in this study and has given a written informed consent, after fully understanding the detailed explanation of this study
Key exclusion criteria (30 listed)
- Subjects with symptoms suggestive of an acute disease at the time of screening
- Subjects with clinically significant and active diseases related to cardiovascular system, gastrointestinal system, respiratory system, endocrine system, neuropsychiatric system, hematologic/oncologic system
- Subjects meeting any of the following criteria based on examination during screening:
- Subjects with systolic blood pressure of 90 mmHg or less, or 150 mmHg or more, or diastolic blood pressure of 50 mmHg or less, or 100 mmHg or more after sitting for at least 5 minutes during screening (Visit 1)
- Subjects meeting any of the following criteria based on ophthalmological examination during screening:
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 |
|---|---|---|
| SCAI-005 0.04% or placeboaxitinib 0.014mg or placebo | Drug | Multiple Ascending Dose, Single Ascending Dose |
| SCAI-005 0.08% or placeboaxitinib 0.028mg or placebo | Drug | Multiple Ascending Dose, Single Ascending Dose |
| SCAI-005 0.08% or placebo 2dropsaxitinib 0.056mg or placebo | Drug | Multiple Ascending Dose, Single Ascending Dose |
Primary outcome
Safety Evaluation: Incidence, type, and severity of Adverse Events (AE)
Time frame: 15days
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 9 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 of Wet Age Related Macular Degeneration, run by SCAI Therapeutics at 1 site in South Korea.
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 3 inclusion and 30 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 9 Sep 2025. 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 South Korea. 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?
Safety Evaluation: Incidence, type, and severity of Adverse Events (AE) (time frame: 15days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2025.