A Controlled Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis

Inclusion Criteria: * Age is between 40 and 80 years of age * Have symptoms of knee osteoarthritis (OA) for at least 6 months * Meet American College of Rheumatology criteria (clinical and radiological) for knee OA * Body mass index (BMI) is less than or equal to 40 kg/m2 * Target knee x-ray grade Kellgren-Lawerence (KL) grade 2 or 3 * Have failed at least one prior conservative therapy for knee OA in last 12 months, which includes physical therapy, NSAIDs, and other pain medications * The knee pain scores during screening and baseline must meet specified qualifying criteria for both the target and the contralateral (non-target) knees * Willing to complete all electronic diaries and only use study-provided acetaminophen for pain management while participating in the study * Have negative pregnancy tests during Screening and prior to injection and will not be pregnant or nursing or plan to be pregnant while participating in the study * Must use a highly effective birth control method if sexually active Exclusion Criteria: * Have taken or had any prohibited medications, supplements, or therapies that could have an influence on study assessments. Some may be permitted with stable dose or after stopping for a period of time. Please refer to physician for further details. * Have active infections or target knee conditions that may compromise study drug administration * Have exclusionary lab values determined during Screening * Have severe hip OA on the same side of the target knee that interferes with assessment of pain in the target knee * Have or had primarily patellofemoral OA, severe malalignment, certain knee surgeries, or other excluded target knee conditions * Have joint disorders, uncontrolled fibromyalgia, or clinically significant conditions that could interfere with study assessments or compromise participant safety * Received another clinical trial therapy, medication, or product with 90 days of Screening * Have non-compliance with study diaries during Screening * Involved in litigation, disability, or worker's compensation matters based on OA pain * Allergic to study drug, HA, placebo, or acetaminophen