NCT06707753

Safety and Tolerability of AL-001 Ophthalmic Injection in Subjects with WAMD

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)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Beijing Anlong Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wet Age-related Macular Degeneration (wAMD)

Interventions

Type	Name	Description
DRUG	AL-001	Administered via suprachoroidal space injection.

Timeline

• Start date: 2023-09-11
• Primary completion: 2025-08-31
• Completion: 2025-08-31
• First posted: 2024-11-27
• Last updated: 2025-03-19

Locations

1 site across 1 country: China