Clinical Research Directory

Inclusion Criteria: 1. Sign informed consent prior to any inspection and evaluation, and understand and follow test requirements; 2. Age 40-75 years old (including boundary value) at the time of signing the informed consent, gender is not limited; 3. Primary knee osteoarthritis was confirmed by clinical and imaging examination; 4. Knee osteoarthritis pain history ≥6 months; 5. Tibial joint X-ray within 3 months prior to drug administration showed that the tibiofemoral joint of the target knee was graded Kellgren-Lawrence II or III; 6. Before the first medication, the WAADPI NRS score of the study knee was ≥5, and the WAADPI NRS score of the contralateral knee was \<4; 7. Be willing to discontinue the use of nonsteroidal anti-inflammatory drugs, acetaminophen, and other pain medications, and only use the acetaminophen provided in the study for emergency treatment of knee osteoarthritis pain during the study period; 8. Body mass index (BMI) ≤40.0 kg/m2. Exclusion Criteria: 1. Secondary arthritis caused by other causes; 2. The study knee has other knee pathologic findings confirmed by clinical evaluation or imaging 3. There are other conditions that can cause study knee pain or other physical pain; 4. Other medications for osteoarthritis were used within 1 week prior to the first dose; 5. Patients with chronic pain in other parts of the body requiring long-term oral analgesic therapy, or those requiring combined treatment with systemic glucocorticoids; 6. Open knee injury or knee surgery occurred in the study knee within 6 months before the first medication; Or have had any major surgical procedures within 3 months prior to the first medication; 7. The study knee has received intra-articular injection treatment (such as steroids or sodium hyaluronate, etc.) within 3 months before the first medication; 8. Received physical therapy for study knee osteoarthritis (such as electrotherapy or acupuncture) within 3 months before the first medication; 9. Used any capsaicin-containing product or non-steroidal anti-inflammatory drug on the knee within 2 weeks prior to the first administration; 10. Have An open wound, skin erythema or edema, skin infection, or any other skin lesion in the study knee prior to initial administration; 11. A history of alcohol or drug dependence within 12 months prior to the first administration or a positive urine drug test during the screening period.