Clinical Trial on the Efficacy and Safety of ALT001 in Osteoarthritis

Inclusion Criteria: 1. Aged 50 to 75 years old (inclusive), gender unrestricted; 2. Body Mass Index (BMI) within the range of 18 ≤ BMI ≤ 35; 3. Meets the diagnostic criteria for osteoarthritis (OA) in Chinese Guidelines for the Diagnosis and Treatment of Osteoarthritis (2021 Edition) \[1\]. A diagnosis of knee osteoarthritis can be made if criterion ① plus any 2 of criteria ②, ③, ④, ⑤ are satisfied: ① Recurrent knee pain within the past 1 month; ② X-ray (standing or weight-bearing position) shows narrowed joint space, subchondral bone sclerosis and/or cystic changes, and osteophyte formation at the joint margin; ③ Aged ≥ 50 years; ④ Morning stiffness duration ≤ 30 minutes; ⑤ Crepitus (sensation or sound) during joint movement; 4. Kellgren-Lawrence grade of Grade Ⅰ to Ⅲ for at least one knee joint on anteroposterior and lateral (stress) X-ray of bilateral knee joints within 6 months; 5. A score of 4 to 8 points (inclusive) for pain on flat ground walking or stair climbing in the WOMAC Pain Score of at least one knee joint; 6. For participants who have been taking glucosamine or diacerein-containing drugs before the screening period, the dosage must be kept stable throughout the entire clinical trial; 7. Discontinued all analgesic drugs for more than 2 weeks before the screening period, and agreed not to use any other analgesic drugs except rescue medication throughout the entire study; 8. Willing to cooperate with the clinical trial and able to sign the informed consent form. Exclusion Criteria: 1. With other diseases that cause knee pain and dysfunction (e.g., autoimmune arthritis, infectious arthritis, gouty arthritis, knee joint tumors, etc.); 2. With pain in other body parts exceeding knee pain, which may interfere with the assessment of the knee joint; 3. With significantly narrowed joint space or bony ankylosis due to bone bridge formation between joints; 4. With lower extremity pain caused by lumbar spinal stenosis or lumbar disc herniation; 5. With systemic infection or severe local infection; 6. With clinically significant abnormalities in any item of the four infectious disease screening tests; 7. With a history of knee joint surgery, open trauma within 1 year, or intra-articular injection, radiotherapy, or arthroscopy within 6 months; 8. With intra-articular corticosteroid block therapy for the knee joint or long-term (continuous ≥2 weeks) use of corticosteroids or immunosuppressants within 6 months; 9. With a history of taking Chinese herbal decoctions or proprietary Chinese medicines for knee pain within 1 month; 10. With physical therapy or topical medication (e.g., electromagnetic therapy, cupping, acupuncture, plasters, fumigation, etc.) on the knee joint within 1 week; 11. With severe diseases of the heart, brain, liver, kidney, hematologic, endocrine, or immune systems (e.g., AST/ALT or creatinine ≥2.0×ULN, glycosylated hemoglobin ≥8%, hemophilia, etc.); 12. With malignant tumors; 13. Planning to undergo elective knee joint surgery during the study period; 14. With obvious knee joint effusion (significant joint swelling or bulging) or severe venous/lymphatic stasis of the lower extremities; 15. Requiring long-term use of warfarin or other anticoagulants (except for a stable daily dose of aspirin ≤100 mg and/or clopidogrel); 16. With consciousness disturbance or mental illness, unable to complete self-assessment; 17. With a history of drug abuse or alcoholism; 18. With a history of allergy to the raw materials of the study product and control product, or atopic diathesis (previous allergy to protein-based drugs or food); 19. With a positive pregnancy test, pregnant/lactating women, those with recent childbearing plans, or those unable to take reliable contraceptive measures during the study; 20. Having participated in other clinical trials of drugs, biological agents, or medical products within 3 months; 21. Other circumstances deemed inappropriate for participation in this clinical trial by the investigator.