Clinical trial NCT05187403: A Study of Laquinimod Eye-drops in Healthy Participants
Official title: A Placebo-Controlled, Double-masked Phase-1 Study in Healthy Subjects Investigating the Safety and Tolerability of Laquinimod Eye Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Eye Diseases
Lead sponsor: Active Biotech AB
Sponsor class: INDUSTRY
First posted: 2022-01-11
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Adverse events
timeFrame: For 7 days post-dose
Secondary outcomes:
measure: Participant-reported eye-toxicities
timeFrame: Pre-dose (baseline) and immediately after the intervention
measure: Investigator-reported eye-toxicities - BCVA
timeFrame: Pre-dose (baseline) and immediately after the intervention
measure: Investigator-reported eye-toxicities - Slit lamp examination
timeFrame: Pre-dose (baseline) and immediately after the intervention
measure: Investigator-reported eye-toxicities - Corneal fluorescein staining
timeFrame: At screening visit (baseline) and immediately after the intervention
measure: Investigator-reported eye-toxicities - Intraocular pressure
timeFrame: At screening visit (baseline) and immediately after the intervention
measure: Investigator-reported eye-toxicities - Funduscopy in mydriasis
timeFrame: At screening visit (baseline) and immediately after the intervention
measure: Peak plasma concentration of laquinimod
timeFrame: Over up to 21 days after (last) dose
measure: Time to peak plasma concentration of laquinimod
timeFrame: Over up to 21 days) after (last) dose
measure: Trough plasma concentration of laquinimod at steady-state
timeFrame: On the last three days of multiple dosing
measure: Systemic exposure of laquinimod
timeFrame: Over up to 21 days after (last) dose
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Clinical trial center at Medical University Vienna
Study officials:
affiliation: Clinical trial center at Medical University Vienna
name: Gerhard Garhöfer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: