Study to Evaluate the Safety and Tolerability of FX201 in Patients with Osteoarthritis of the Knee

This two-part study will be conducted in male and female patients, 30 - 80 years of age with painful OA of the index knee with Kellgren-Lawrence (K-L) Grade 2, 3 or 4. Part 1 - Single Ascending Dose (SAD) Phase: Up to three ascending doses of FX201 will be tested in cohorts of 5-8 patients. Each patient will only receive one injection of FX201. An independent Data Monitoring Committee (DMC) will review safety and guide the conduct of the study. Part 2 - Expansion Phase: Up to an additional 35 patients will be enrolled at each dose level reviewed by the DMC. Each patient will only receive one injection of FX201.

NCT Number	NCT04119687
Lead Sponsor	Pacira Pharmaceuticals, Inc
Conditions	Osteoarthritis, Knee
Enrollment	72 participants
Start Date	2020-03-02
Primary Completion	2023-11-28 (estimated)
Study Completion	2026-11-28 (estimated)
Updated on ClinicalTrials.gov	2025-03-17