Loading clinical trials...

Clinical Study for the Evaluation of Safety and Tolerability of SCAI-005 Eye Drops | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Clinical Study for the Evaluation of Safety and Tolerability of SCAI-005 Eye Drops

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

NCT06969001•SCAI Therapeutics

View on ClinicalTrials.gov

Summary

To assess the single-dose and multiple-dose pharmacokinetics (PK), safety and tolerability of SCAI-005 eyedrops(axitinib) in healthy volunteers

Eligibility

Age

19 - 50 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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

Exclusion Criteria

•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:
•1. AST, ALT \> 1.5 X ULN
•2. Total bilitubin \> 1.5 X ULN
•3. eGFR (estimated Glomerular Filtration Rate) \< 90 mL/min/1.73 m2
•4. 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:
•1. Best corrected visual acuity \< 0.6
+20 more criteria

Locations (1)

The Catholic University, Seoul ST. Mary's Hospital

Seoul, South Korea

Key Dates

Start Date

May 29, 2025

Primary Completion Date

September 4, 2025

Completion Date

September 4, 2025

Last Updated

September 9, 2025

Enrollment

ACTUAL participants

Conditions

Wet Age Related Macular Degeneration

Interventions

SCAI-005 0.04% or placebo

DRUG

SCAI-005 0.08% or placebo

DRUG

SCAI-005 0.08% or placebo 2drops

DRUG

A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will be Determined at Week 56

NCT06683742

View study

COMPLETED

CRYSTALSIGHT: ''Cohort 1.5" Clinical Investigation Study With OCCUTRACK and Tan Tock Seng Eye Clinic to Further Develop Remote Monitoring of Maculopathy at Home Using Artificial Intelligence for Eye Tracking

NCT07255885

MaculopathyMaculopathy, Age Related+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Clinical Study for the Evaluation of Safety and Tolerability of SCAI-005 Eye Drops

Inclusion Criteria

Exclusion Criteria

A 2-year Study of EYP-1901 in Subjects With Wet Age Related Macular Degeneration (wAMD) (LUCIA) Primary Efficacy Will be Determined at Week 56

CRYSTALSIGHT: ''Cohort 1.5" Clinical Investigation Study With OCCUTRACK and Tan Tock Seng Eye Clinic to Further Develop Remote Monitoring of Maculopathy at Home Using Artificial Intelligence for Eye Tracking

Optical Coherence Tomography Angiography Criteria Of The Choroidal Neovascular Membrane In Wet Age Related Macular Degeneration And In Pathological Myopia (Comparative Study).