ArticleOphthalmology science2026
Phase I Randomized Study of SCAI-005 Ophthalmic Solution: Safety, Tolerability, and Pharmacokinetics in Healthy Korean Adults.
Article in Ophthalmology science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Purpose: To evaluate the safety, tolerability, and pharmacokinetic (PK) profiles of SCAI-005-a topical ophthalmic solution of axitinib for neovascular age-related macular degeneration (AMD), a VEGF receptor tyrosine kinase inhibitor-following single and multiple ascending doses (SAD and MAD) in healthy Korean adults. Design: Randomized, double-masked, placebo-controlled, single- and multiple-ascending-dose phase I study. Subjects: Forty-eight healthy Korean adults were randomized 3:1 (active:placebo) into six cohorts across SAD (0.04% as a single drop, 0.08% as a single drop, and 0.08% as two drops) and MAD (0.04% 1 drop three times daily (TID), 0.08% 1-drop TID, and 0.08% two-drop TID for 7 days) groups. Methods: SCAI-005 or placebo was administered topically to 1 eye per subject. Serial blood samples were collected for systemic PK analysis using noncompartmental analysis. Safety was assessed through treatment-emergent adverse events (TEAEs), ophthalmic examinations, vital signs, electrocardiography, and clinical laboratory tests. Main Outcome Measures: Primary outcomes were safety and tolerability. Secondary outcomes included systemic PK parameters (C Results: Forty-seven of 48 subjects (97.9%) completed the study. TEAEs were reported in 7 subjects (14.6%), with no obvious dose-dependent trend in this small sample. All treatment-related TEAEs were grade 1 in severity. No clinically significant changes were observed in ophthalmic assessments. SCAI-005 was rapidly absorbed following topical administration, with day 8 postdose peak systemic concentrations (C Conclusions: Topical SCAI-005 was generally well tolerated in this small first-in-human study in healthy Korean adults, producing low systemic axitinib exposure and no obvious short-term safety signal. These findings will require confirmation in phase II studies enrolling the target neovascular AMD population. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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