Clinical Research Directory

Inclusion Criteria: 1. 18-75 years of age (inclusive of 18 and 75 years), regardless of gender; 2. Diagnosed of definite or probable ALS according to the revised EI Escorial criteria; 3. Respiratory function FVC at baseline was ≥70% of the predicted value (FVC%); 4. Patients with birth-potential (both male and female) must agree to use effective non-drug contraceptive measures from the time of signing the informed consent until 6 months after the conclusion of the trial; 5. Volunteer to participate in the clinical study, understand and sign the informed consent form. Exclusion Criteria: 1. Subject has signs and symptoms of neuromuscular weakness, and other causes of muscle weakness cannot be ruled out; 2. Baseline body mass index (BMI) \< 18.5 kg/m²; 3. Primary lateral sclerosis presenting only with upper motor neuron symptoms; 4. Significant psychiatric disorders that the investigator assesses may affect evaluation; 5. Diseases causing neurological or muscular dysfunction, such as metabolic muscle diseases or myasthenia gravis; 6. Diagnosed autoimmune diseases with uncontrolled severe arthritis or other conditions (e.g., lameness) that the investigator assesses may affect evaluation; 7. Acute active infections requiring antibiotics, antivirals, or antifungals that occurred within the 2 weeks prior to screening and are not controlled; 8. Subject diagnosed with active pulmonary tuberculosis or treated for suspected tuberculosis; 9. Diagnosed severe pulmonary diseases that the investigator assesses may affect evaluation; 10. Poorly controlled hypertension; 11. Previous or detected cardiac abnormalities; 12. A history of cirrhosis, chronic hepatitis, or liver function at screening; 13. A history of chronic kidney disease; 14. Previous history of bleeding, abnormal clotting, or being treated with anticoagulation; 15. Active hepatitis B, active hepatitis C, human immunodeficiency virus (HIV) antibody or treponema pallidum antibody positive at screening; 16. History of severe trauma or surgery and may affect the assessment judged by investigator; 17. Subjects with contraindications to lumbar puncture, including menifestations of injection site infection or high intracranial pressure. 18. Those who have had a malignant tumor within 5 years prior to screening or are undergoing antitumor therapy; 19. Have participated in other clinical trials within 3 months prior to screening; 20. Pregnant or breastfeeding women; 21. Subject who is judged by the investigator to be unsuitable for the clinical trial.