Arthritis Clinical Trials

This study will be an open-label, single administration design, conducted in patients with OA of the knee.

Patients will be enrolled sequentially with 8 to 10 patients per Cohort as follows:

Cohort A: FX006 40mg, Final Visit at Week 20 Cohort B: FX006 40 mg, Final Visit at Week 16 Cohort C: FX006 10 mg, Final Visit at Week 12 Cohort D: FX006 40 mg, Final Visit at Week 12

Each patient will be evaluated for up to 12, 16 or 20 weeks following a single intra-articular (IA) injection of FX006 at 10 mg or 40 mg, depending on the assigned Cohort. Following the screening visit, safety will be evaluated at three (3) out-patient visits and synovial fluid will be collected at Day 1 for baseline measurements and the Final Visit for drug concentration measurements.