Evaluation of Intra-articular CX-011 to Treat Moderate to Severe Pain From Knee Osteoarthritis

The primary objective of the study is to assess the safety and tolerability of three escalating doses of CX-011 (100, 300, and 1000 μg) following a single intra-articular administration. Safety assessments will include the incidence and severity of local and systemic adverse events, procedure- and product-related serious adverse events, physical examinations, index knee evaluations, vital signs, electrocardiograms, and safety laboratory tests. Dose-limiting toxicities and the maximum tolerated dose will be determined based on these assessments. Secondary objectives focus on evaluating the preliminary efficacy of CX-011 for the treatment of knee osteoarthritis pain and function, as well as further characterization of its safety profile. Efficacy endpoints include changes from baseline in pain intensity measured by the Visual Analog Scale (VAS) at 4, 12, and 24 weeks post-injection, as well as percentage improvements in the pain and function subscales of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at the same time points. Up to 72 patients will participate in this study (in one study center). The expected length of participation in the study is about 28 weeks including the screening period.