65
Participants
Start Date
July 15, 2019
Primary Completion Date
October 10, 2024
Study Completion Date
January 31, 2025
FX006 Injection
One injection of extended release triamcinolone. 32 milligram injection of the extended release triamcinolone in a 75:25 ratio of polylactic-co-glycolic acid (PLGA) microspheres to drug load of 25%. The drug product is reconstituted with diluent containing an isotonic, sterile aqueous solution of sodium chloride, carboxymethylcellulose sodium and polysorbate-80 to form a suspension prior to injection.
Northwell Health Orthopedic Institute at Great Neck, Great Neck
Lead Sponsor
Northwell Health
OTHER