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Eye DiseasesPhase 1NCT05187403

A Study of Laquinimod Eye-drops in Healthy Participants

A Phase 1 study testing Laquinimod in people with Eye Diseases, run by Active Biotech AB at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Eye Diseases
What is being tested?
Laquinimod
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteAustria
Study dates
9 Dec 2021to 19 Jan 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

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

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Clinical trial center at Medical University Vienna

    Vienna

Other trials in Austria

About this study

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

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.

Read the 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
Being tested
Laquinimod, Placebo
Medical subject headings
Eye Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LaquinimodDrug

    Also called TV-5600, ABR-215062

    Eye-drops

  • PlaceboDrug

    Eye-drops

Study groups in NCT05187403
Study groupRoleWhat they receive
Laquinimod - Single Ascending DosesExperimentalOne single dose of laquinimod eye-drops. There are up to four planned dose levels.
Receives: Drug: Laquinimod
Placebo - Single Ascending DosesPlacebo comparatorOne single dose of placebo eye-drops.
Receives: Drug: Placebo
Laquinimod - Multiple Ascending DosesExperimentalEye-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.
Receives: Drug: Laquinimod
Placebo - Multiple Ascending DosesPlacebo comparatorEye-drops administered once daily for 14-21 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Type, frequency, seriousness, severity and relationship to treatment

    Measured: For 7 days post-dose

Secondary outcomes (10)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. Investigator-reported eye-toxicities - Intraocular pressure

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

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

  6. 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.

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

  7. 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

    Measured: Over up to 21 days after (last) dose

  8. 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

    Measured: Over up to 21 days) after (last) dose

  9. 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

    Measured: On the last three days of multiple dosing

  10. Systemic exposure of laquinimod

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

    Measured: Over up to 21 days after (last) dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2022
  2. Study start9 Dec 2021
  3. Primary completion19 Jan 2023
  4. Study completion19 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05187403
Sponsor's protocol ID
21LAQ01
Other IDs
2021-004029-60
Status last verified
Jan 2023
First submitted
6 Dec 2021
Last updated
31 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Laquinimod in people with Eye Diseases, run by Active Biotech AB at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: For 7 days post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05187403.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2023.

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