Status:
COMPLETED
A Study of Laquinimod Eye-drops in Healthy Participants
Lead Sponsor:
Active Biotech AB
Conditions:
Eye Diseases
Eligibility:
MALE
18-35 years
Phase:
PHASE1
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 w...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 19 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05187403
Start Date
December 9 2021
End Date
January 19 2023
Last Update
January 31 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clinical trial center at Medical University Vienna
Vienna, Austria