A Study of Laquinimod Eye-drops in Healthy Participants

NCT ID: NCT05187403

Last Updated: 2023-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-09
• Study Completion Date: 2023-01-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Laquinimod - Single Ascending Doses

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

Group Type: EXPERIMENTAL

Laquinimod

Intervention Type: DRUG

Eye-drops

Placebo - Single Ascending Doses

One single dose of placebo eye-drops.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Eye-drops

Laquinimod - Multiple Ascending Doses

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.

Group Type: EXPERIMENTAL

Laquinimod

Intervention Type: DRUG

Eye-drops

Placebo - Multiple Ascending Doses

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Eye-drops

Interventions

Laquinimod

Eye-drops

Intervention Type: DRUG

Placebo

Eye-drops

Intervention Type: DRUG

Other Intervention Names

TV-5600; ABR-215062

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Active Biotech AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerhard Garhöfer, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical trial center at Medical University Vienna

Locations

Clinical trial center at Medical University Vienna

Vienna, , Austria

Countries

Austria

Other Identifiers

2021-004029-60

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

21LAQ01

Identifier Type: -

Identifier Source: org_study_id