A Study of Laquinimod Eye-drops in Healthy Participants

NCT05187403 | Completed Phase 1

• 2 other identifiers: 21LAQ012021-004029-60
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Diseases

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Type, frequency, seriousness, severity and relationship to treatment

  For 7 days post-dose

Secondary Outcomes (10)

• Participant-reported eye-toxicities

  Pre-dose (baseline) and immediately after the intervention

• Investigator-reported eye-toxicities - BCVA

  Pre-dose (baseline) and immediately after the intervention

• Investigator-reported eye-toxicities - Slit lamp examination

  Pre-dose (baseline) and immediately after the intervention

• Investigator-reported eye-toxicities - Corneal fluorescein staining

  At screening visit (baseline) and immediately after the intervention

• Investigator-reported eye-toxicities - Intraocular pressure

  At screening visit (baseline) and immediately after the intervention

Study Arms (4)

Laquinimod - Single Ascending Doses

EXPERIMENTAL

One single dose of laquinimod eye-drops. There are up to four planned dose levels.

Drug: Laquinimod

Placebo - Single Ascending Doses

PLACEBO COMPARATOR

One single dose of placebo eye-drops.

Drug: Placebo

Laquinimod - Multiple Ascending Doses

EXPERIMENTAL

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.

Drug: Laquinimod

Placebo - Multiple Ascending Doses

PLACEBO COMPARATOR

Eye-drops administered once daily for 14-21 days.

Drug: Placebo

Interventions

Laquinimod DRUG

Eye-drops

Also known as: TV-5600, ABR-215062

Laquinimod - Multiple Ascending Doses; Laquinimod - Single Ascending Doses

Placebo DRUG

Eye-drops

Placebo - Multiple Ascending Doses; Placebo - Single Ascending Doses

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• In good health according to medical history, physical examination, vital signs, ECG and clinical chemistry, urinary and hematological laboratory tests

You may not qualify if:

• 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

Sponsors & Collaborators

• Active Biotech AB: lead

Study Sites (1)

Clinical trial center at Medical University Vienna

Vienna, Austria

Location

MeSH Terms

Conditions

Eye Diseases

Interventions

laquinimod

Study Officials

• Gerhard Garhöfer, MD PhD

  Clinical trial center at Medical University Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: January 11, 2022
• Study Start: December 9, 2021
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)