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.

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.

Main inclusion criteria:

• In good health according to medical history, physical examination, vital signs, ECG and clinical chemistry, urinary and hematological laboratory tests

Main exclusion criteria:

• Unable or unwilling to use eye-drops
• Current usage of contact lenses
• History of eye surgery
• Sign or symptom of active eye disease
• History of an eye disease or other condition that could interfere with eye examinations in the study, or with ocular absorption of the investigational product
• History of inflammatory ocular disease
• History of cardiovascular or pulmonary disorder
• Family history of known or suspected hereditary cardiovascular disease
• Autoimmune disease or known family history of autoimmune disease
• Any other condition that would contraindicate subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures