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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05187403
Other study ID # 21LAQ01
Secondary ID 2021-004029-60
Status Completed
Phase Phase 1
First received
Last updated
Start date December 9, 2021
Est. completion date January 19, 2023

Study information

Verified date January 2023
Source Active Biotech AB
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date January 19, 2023
Est. primary completion date January 19, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Laquinimod
Eye-drops
Placebo
Eye-drops

Locations

Country Name City State
Austria Clinical trial center at Medical University Vienna Vienna

Sponsors (1)

Lead Sponsor Collaborator
Active Biotech AB

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events Type, frequency, seriousness, severity and relationship to treatment For 7 days post-dose
Secondary 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. Pre-dose (baseline) and immediately after the intervention
Secondary 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. Pre-dose (baseline) and immediately after the intervention
Secondary 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. Pre-dose (baseline) and immediately after the intervention
Secondary 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. At screening visit (baseline) and immediately after the intervention
Secondary Investigator-reported eye-toxicities - Intraocular pressure Assessed from change from baseline in intraocular pressure (mmHg) determined using a Goldmann applanation tonometer. At screening visit (baseline) and immediately after the intervention
Secondary 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. At screening visit (baseline) and immediately after the intervention
Secondary 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 Over up to 21 days after (last) dose
Secondary 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 Over up to 21 days) after (last) dose
Secondary 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 On the last three days of multiple dosing
Secondary Systemic exposure of laquinimod Area under the plasma concentration time curve (AUC) of laquinimod Over up to 21 days after (last) dose
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