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Clinical Trial 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.

Clinical Trial 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-dose (MD) 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 MD-part of the study will enroll another 14 participants. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05187403
Study type Interventional
Source Active Biotech AB
Contact Eva Bondesson, PhD
Phone +46 46 192000
Email [email protected]
Status Recruiting
Phase Phase 1
Start date December 9, 2021
Completion date June 2022

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