NCT06161415

Safety, Tolerability, and Distribution of Laquinimod Eye Drops : The LION Study

Safety, Tolerability, and Distribution of Topical Laquinimod Eye Drops , an Innovative ImmunomodulatOr Targeting Aryl hydrocarboN Receptor (AhR): The LION Study

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Quan Dong Nguyen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The LION Study is a prospective, single-center phase 1 clinical trial to evaluate the safety, tolerability, and distribution of Laquinimod administered as topical eye drops for two weeks in human participants.

Detailed description

Participants who fulfill the study eligibility criteria and who are planned to undergo a pars plana vitrectomy will be enrolled in the study. Eligible participants scheduled for a diagnostic vitrectomy may also be enrolled. The study will consist of two stages: Stage One - Open label dose escalation: Up to three subsequent dose-escalation groups will receive Laquinimod eye drops for 2 weeks and samples will be assayed for Laquinimod concentration in aqueous humor, vitreous and plasma. Stage Two- Randomized, Controlled Comparison of 2 Laquinimod doses: After the dose escalation cohorts are analysed, 2 Laquinimod doses will be selected for a randomized comparison. The doses in stage 2 will not exceed those studied in stage 1.

Conditions

• Inflammation
• Uveitis

Interventions

Type	Name	Description
DRUG	Laquinimod eye drops	n Laquinimod eye drops 10 mg/ml Dose: Dosing frequency will depend on the groups assigned

Timeline

• Start date: 2024-05-03
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2023-12-07
• Last updated: 2025-05-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study