NCT05187403

A Study of Laquinimod Eye-drops in Healthy Participants

A Placebo-Controlled, Double-masked Phase-1 Study in Healthy Subjects Investigating the Safety and Tolerability of Laquinimod Eye Drops

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Active Biotech AB · Industry
• Sex: Male
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1 randomized, double-masked, placebo-controlled study performed with healthy participants to assess the safety and tolerability of laquinimod eye-drops.

Detailed description

Laquinimod administered as an oral capsule formulation has previously been studied in neurodegenerative and autoimmune diseases. The clinical side effect profile of orally administered laquinimod is well-characterized based on this previous experience. This trial will establish a safe and tolerated dose of laquinimod when administered as an eye-drop formulation following single ascending dose (SAD) and multiple ascending dose (MAD) administrations. There are four planned groups in the SAD-part of the study which will enroll 28 participants, if all dose levels are explored. The subsequent MAD-part of the study will enroll another 28 participants.

Conditions

• Eye Diseases

Interventions

Type	Name	Description
DRUG	Laquinimod	Eye-drops
DRUG	Placebo	Eye-drops

Timeline

• Start date: 2021-12-09
• Primary completion: 2023-01-19
• Completion: 2023-01-19
• First posted: 2022-01-11
• Last updated: 2023-01-31

Locations

1 site across 1 country: Austria