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Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with WAMD
Sponsor: Beijing Anlong Biopharmaceutical Co., Ltd.
Summary
This Phase I/IIa study is designed to evaluate the safety, tolerability, preliminary pharmacodynamics and pharmacokinetics in patients with wet age-related macular degeneration. Eligible patients, who meet the inclusion/exclusion criteria and have shown an anatomic response to an anti-VEGF (Vascular Endothelial Growth Factor) injection, will receive a single dose of AL-001 administered via suprachoroidal space injection.
Official title: An Open-label, Nonrandomized, Single-arm, Single Dose, Dose-escalation Phase I/IIa Study to Evaluate the Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with Wet Age-related Macular Degeneration (wAMD)
Key Details
Gender
All
Age Range
50 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
21
Start Date
2023-09-11
Completion Date
2025-08-31
Last Updated
2025-03-19
Healthy Volunteers
No
Interventions
AL-001
Administered via suprachoroidal space injection.
Locations (1)
Chinese Academy of Medical Sciences & Peking Union Hospital
Beijing, China