Study to Evaluate a Procedure for Intra-articular Injection of FX006 in Patients With Osteoarthritis of the Hip

Exclusion Criteria

• •Has a history of hypersensitivity to triamcinolone acetonide, PLGA or lidocaine
• •Is receiving anticoagulants (including warfarin, dabigatran, rivaroxaban, apixaban or low molecular weight heparin, ritonavir or cobicistat)
• •Has had any previous surgery on the index hip
• •Presence of surgical hardware or other foreign body in the index hip
• •Has a history of infection of the index hip
• •Has a diagnosis of other disorders in the index hip that can cause pain
• •Has received any intra-articular injection in the index hip of corticosteroids, investigational (including FX006) or marketed (including Zilretta®) within the 3 months prior to Screening
• •Has had trauma to the index hip in the past 3 months requiring immobilization
• •Has a history or evidence of active or latent systemic fungal or mycobacterial infection (including tuberculosis), or of ocular herpes simplex
• •Has within the past 3 months received corticosteroids by mouth, or by parenteral injection. Multiple courses or chronic intermittent use of inhaled, intranasal, or topical steroids is also exclusionary. Single courses of 14 days or less by those routes are permitted
• •Has, at screening, or any time prior to day of scheduled injection (Day 1), clinical suspicion of local or systemic infection, including any infection in the index leg.
• •Has a history of or active significant concomitant illness (known or suspected)
• •Any bacterial or viral infection requiring parental antibiotics within 4 weeks of Day 1 or oral antibiotics within 2 weeks of Day 1
• •Is a woman who is pregnant, nursing, lactating, or plans to become pregnant during the study
• •Is a man who plans to conceive during the study