Back to resultsA Study of Laquinimod Eye-drops in Healthy Participants
Primary Purpose
Eye Diseases
Status
Completed
Phase
Phase 1
Locations
Austria
Study Type
Interventional
Intervention
Laquinimod
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Eye Diseases
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
Sites / Locations
- Clinical trial center at Medical University Vienna
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Laquinimod - Single Ascending Doses
Placebo - Single Ascending Doses
Laquinimod - Multiple Ascending Doses
Placebo - Multiple Ascending Doses
Arm Description
One single dose of laquinimod eye-drops. There are up to four planned dose levels.
One single dose of placebo eye-drops.
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.
Eye-drops administered once daily for 14-21 days.
Outcomes
Primary Outcome Measures
Adverse events
Type, frequency, seriousness, severity and relationship to treatment
Secondary Outcome Measures
Participant-reported eye-toxicities
Assessed from change from baseline in ocular symptoms score determined using a Visual Analogue Scale with 0-100 range, where 0= no symptom and 100= worst possible discomfort.
Investigator-reported eye-toxicities - BCVA
Assessed from change from baseline in Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study research group (ETDRS) visual acuity chart with objective and subjective refraction.
Investigator-reported eye-toxicities - Slit lamp examination
Assessed from change from baseline in slit lamp examination parameters (eyelid swelling, eyelid redness, conjunctival redness, conjunctival chemosis, scleral redness, corneal opacity, iris alterations and anterior chamber flare) graded on a 4-point scale where 0= none, 1= mild, 2= moderate, and 3= severe.
Investigator-reported eye-toxicities - Corneal fluorescein staining
Assessed from change from baseline in corneal fluorescein staining determined using the NEI/Industry Workshop guidelines. The cornea is divided into five sectors (central, superior, inferior, nasal and temporal) and each sector scored on a 4-point scale, where 0= no staining and 3= maximum staining.
Investigator-reported eye-toxicities - Intraocular pressure
Assessed from change from baseline in intraocular pressure (mmHg) determined using a Goldmann applanation tonometer.
Investigator-reported eye-toxicities - Funduscopy in mydriasis
Assessed from change from baseline in clinical signs detected by indirect funduscopic inspection of the optic disc, macula, retinal vessels and retinal periphery.
Peak plasma concentration of laquinimod
Maximal plasma concentration (Cmax) of laquinimod as assessed from samples collected pre-dose and at frequent intervals over 7 days after (last) dose
Time to peak plasma concentration of laquinimod
Time to maximal plasma concentration (tmax) of laquinimod as assessed from samples collected pre-dose and at frequent intervals over 7 days after (last) dose
Trough plasma concentration of laquinimod at steady-state
Minimal plasma concentration (Cmin,ss) of laquinimod as assessed from samples collected pre-dose on Days 12, 13 and 14 within the multiple-dose arm
Systemic exposure of laquinimod
Area under the plasma concentration time curve (AUC) of laquinimod
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05187403
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 9, 2021 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
January 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Active Biotech AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laquinimod - Single Ascending Doses
Arm Type
Experimental
Arm Description
One single dose of laquinimod eye-drops. There are up to four planned dose levels.
Arm Title
Placebo - Single Ascending Doses
Arm Type
Placebo Comparator
Arm Description
One single dose of placebo eye-drops.
Arm Title
Laquinimod - Multiple Ascending Doses
Arm Type
Experimental
Arm 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.
Arm Title
Placebo - Multiple Ascending Doses
Arm Type
Placebo Comparator
Arm Description
Eye-drops administered once daily for 14-21 days.
Intervention Type
Drug
Intervention Name(s)
Laquinimod
Other Intervention Name(s)
TV-5600, ABR-215062
Intervention Description
Eye-drops
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Eye-drops
Primary Outcome Measure Information:
Title
Adverse events
Description
Type, frequency, seriousness, severity and relationship to treatment
Time Frame
For 7 days post-dose
Secondary Outcome Measure Information:
Title
Participant-reported eye-toxicities
Description
Assessed from change from baseline in ocular symptoms score determined using a Visual Analogue Scale with 0-100 range, where 0= no symptom and 100= worst possible discomfort.
Time Frame
Pre-dose (baseline) and immediately after the intervention
Title
Investigator-reported eye-toxicities - BCVA
Description
Assessed from change from baseline in Best Corrected Visual Acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study research group (ETDRS) visual acuity chart with objective and subjective refraction.
Time Frame
Pre-dose (baseline) and immediately after the intervention
Title
Investigator-reported eye-toxicities - Slit lamp examination
Description
Assessed from change from baseline in slit lamp examination parameters (eyelid swelling, eyelid redness, conjunctival redness, conjunctival chemosis, scleral redness, corneal opacity, iris alterations and anterior chamber flare) graded on a 4-point scale where 0= none, 1= mild, 2= moderate, and 3= severe.
Time Frame
Pre-dose (baseline) and immediately after the intervention
Title
Investigator-reported eye-toxicities - Corneal fluorescein staining
Description
Assessed from change from baseline in corneal fluorescein staining determined using the NEI/Industry Workshop guidelines. The cornea is divided into five sectors (central, superior, inferior, nasal and temporal) and each sector scored on a 4-point scale, where 0= no staining and 3= maximum staining.
Time Frame
At screening visit (baseline) and immediately after the intervention
Title
Investigator-reported eye-toxicities - Intraocular pressure
Description
Assessed from change from baseline in intraocular pressure (mmHg) determined using a Goldmann applanation tonometer.
Time Frame
At screening visit (baseline) and immediately after the intervention
Title
Investigator-reported eye-toxicities - Funduscopy in mydriasis
Description
Assessed from change from baseline in clinical signs detected by indirect funduscopic inspection of the optic disc, macula, retinal vessels and retinal periphery.
Time Frame
At screening visit (baseline) and immediately after the intervention
Title
Peak plasma concentration of laquinimod
Description
Maximal plasma concentration (Cmax) of laquinimod as assessed from samples collected pre-dose and at frequent intervals over 7 days after (last) dose
Time Frame
Over up to 21 days after (last) dose
Title
Time to peak plasma concentration of laquinimod
Description
Time to maximal plasma concentration (tmax) of laquinimod as assessed from samples collected pre-dose and at frequent intervals over 7 days after (last) dose
Time Frame
Over up to 21 days) after (last) dose
Title
Trough plasma concentration of laquinimod at steady-state
Description
Minimal plasma concentration (Cmin,ss) of laquinimod as assessed from samples collected pre-dose on Days 12, 13 and 14 within the multiple-dose arm
Time Frame
On the last three days of multiple dosing
Title
Systemic exposure of laquinimod
Description
Area under the plasma concentration time curve (AUC) of laquinimod
Time Frame
Over up to 21 days after (last) dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Garhöfer, MD PhD
Organizational Affiliation
Clinical trial center at Medical University Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical trial center at Medical University Vienna
City
Vienna
Country
Austria
12. IPD Sharing Statement
Plan to Share IPD
No
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A Study of Laquinimod Eye-drops in Healthy Participants
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