Phase IIa, Randomized, Double Blinded, Placebo Controlled, Dose Finding Study for TLC599 in OA Patients

Exclusion Criteria

• •1. Patients who received systemic corticosteroids within the last 30 days prior to dosing.
• •2. Patients who use prohibited medications within 7 days prior to study drug administration or any pain control medication including acetaminophen within 48 hours prior to study drug administration.
• •3. Patients who use prohibited medications other than acetaminophen and oral NSAIDs from screening visit to 7 days prior to study drug administration.
• •4. Documented history and confirmed autoimmune disease
• •5. History of post-traumatic knee arthritis, or evidence of intra articular bleeding of the study knee
• •6. History of infective arthritis
• •7. Unstable study knee joint
• •8. Use of IA corticosteroid, hyaluronic acid, or other IA injection in the study knee within 3 months prior to the screening visit.
• •9. A history of treated malignancy which is disease free for ≤ 5 years prior to the screening visit
• •10. Uncontrolled and unstable concurrent medical or psychiatric illness, that will jeopardize the safety of the patient
• •11. Use of any chemotherapeutic or systemic immunosuppressant agents for inflammatory diseases within 6 months prior to the screening visit.
• •12. Current use of anticoagulants, including warfarin, heparin, low molecular weight heparin, or dabigatran.
• •13. Abnormalities of laboratory parameters as described below will qualify for exclusion:
• •* hemoglobin \< 8 g/dL;
• •* total white blood cell count \< 4000/ µL;
• •* serum bilirubin/ alanine aminotransferase/ aspartate aminotransferase \> 2 times upper limit of normal (ULN) for the laboratory reference ranges;
• •* serum creatinine \> 2 times ULN for the laboratory reference range;
• •* serum uric acid \> ULN for the laboratory reference range;
• •* prothrombin time/International Normalized Ratio \> ULN for the laboratory reference range.
• •14. Contraindication to undergoing magnetic resonance imaging (MRI)