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NCT Number: NCT05187403

A Study of Laquinimod Eye-drops in Healthy Participants

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.

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Key information

Conditions

Eye Diseases

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Clinical trial center at Medical University Vienna

Vienna, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laquinimod

Drug

Eye-drops

Other names: TV-5600, ABR-215062

Placebo

Drug

Eye-drops

Primary outcomes

  1. Adverse events

    Time frame: For 7 days post-dose

    Type, frequency, seriousness, severity and relationship to treatment

Secondary outcomes

  1. Participant-reported eye-toxicities

    Time frame: Pre-dose (baseline) and immediately after the intervention

    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.

  2. Investigator-reported eye-toxicities - BCVA

    Time frame: Pre-dose (baseline) and immediately after the intervention

    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.

  3. Investigator-reported eye-toxicities - Slit lamp examination

    Time frame: Pre-dose (baseline) and immediately after the intervention

    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.

  4. Investigator-reported eye-toxicities - Corneal fluorescein staining

    Time frame: At screening visit (baseline) and immediately after the intervention

    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.

  5. Investigator-reported eye-toxicities - Intraocular pressure

    Time frame: At screening visit (baseline) and immediately after the intervention

    Assessed from change from baseline in intraocular pressure (mmHg) determined using a Goldmann applanation tonometer.

  6. Investigator-reported eye-toxicities - Funduscopy in mydriasis

    Time frame: At screening visit (baseline) and immediately after the intervention

    Assessed from change from baseline in clinical signs detected by indirect funduscopic inspection of the optic disc, macula, retinal vessels and retinal periphery.

  7. Peak plasma concentration of laquinimod

    Time frame: Over up to 21 days after (last) dose

    Maximal plasma concentration (Cmax) of laquinimod as assessed from samples collected pre-dose and at frequent intervals over 7 days after (last) dose

  8. Time to peak plasma concentration of laquinimod

    Time frame: Over up to 21 days) after (last) dose

    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

  9. Trough plasma concentration of laquinimod at steady-state

    Time frame: On the last three days of multiple dosing

    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

  10. Systemic exposure of laquinimod

    Time frame: Over up to 21 days after (last) dose

    Area under the plasma concentration time curve (AUC) of laquinimod

Sponsors and collaborators

Lead sponsor

Active Biotech AB

Industry

Registry information

Official study title

A Placebo-Controlled, Double-masked Phase-1 Study in Healthy Subjects Investigating the Safety and Tolerability of Laquinimod Eye Drops

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jan 11, 2022
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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