A Study of Laquinimod Eye-drops in Healthy Participants

Active Biotech

Status and phase: Completed; Phase 1

Conditions: Eye Diseases

Treatments: Drug: Placebo; Drug: Laquinimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT05187403

21LAQ01

2021-004029-60 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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54 participants in 4 patient groups, including a placebo group

Laquinimod - Single Ascending Doses

Experimental group

Description:

One single dose of laquinimod eye-drops. There are up to four planned dose levels.

Treatment:

Drug: Laquinimod

Placebo - Single Ascending Doses

Placebo Comparator group

Description:

One single dose of placebo eye-drops.

Treatment:

Drug: Placebo

Laquinimod - Multiple Ascending Doses

Experimental group

Description:

Eye-drops administered once daily for 14-21 days. There are up to two planned dose levels. The first dose level will be defined in the SAD-part of the study.

Treatment:

Drug: Laquinimod

Placebo - Multiple Ascending Doses

Placebo Comparator group

Description:

Eye-drops administered once daily for 14-21 days.

Treatment:

Drug: Placebo