Amyotrophic lateral sclerosis (ALS)
Conditions
Interventions
Experimental group:HS-03 injection is treated with 1 injection of the drug once a week, the dose is 0.2mg/dose, and it is injected subcutaneously.
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-80 years old, gender is not limited; 2. Diagnosis of ALS that meets the ALS2020 diagnostic criteria (Gold Coast criteria) for confirmed and proposed diagnosis; 3. ALSFRS-R decreased by 1-6 points within 3 months of the screening period (>=1 and <=6); 4. Subjects need to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with other neurological diseases that are similar to ALS symptoms or affect the evaluation of drug effectiveness, such as cervical myelopathy, lumbar spine disease, dementia, etc.; 2. Patients with other autoimmune diseases, such as multiple sclerosis, polymyositis, myasthenia gravis, Guillain-Barré syndrome, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus, vitiligo, etc.; 3. Severe renal insufficiency: creatinine clearance 3 times the upper limit of normal value, or other known liver diseases such as acute and chronic active hepatitis, cirrhosis, etc.; 5. Patients with acute myocardial infarction or interventional treatment in the past 6 months during the screening period (patients with grade III-IV according to NYHA); 6. Patients with severe pulmonary insufficiency such as COPD and pulmonary fibrosis; 7. Patients with other serious primary diseases and mental illness such as severe nervous system, heart, lung, hematopoietic system or endocrine system; 8. Those who suspect or have a history of alcohol or drug abuse; 9. Patients with SOD1 gene mutation; 10. Critically ill patients with ALSFRS-R score of less than 8 points; 11. Pregnant or lactating women, subjects of childbearing age (including male subjects with heterosexual sex and their female partners of childbearing potential) who have a pregnancy plan or are unwilling to take effective contraceptive measures within 3 months from the start of screening to discontinuation of the drug; 12. Participated in other drug clinical trials within 30 days before screening, or is participating in other clinical trials; 13. The investigator believes that he is not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluation index;Efficacy index ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunological index;Neurofilament light chain,NFL; | — |
Countries
China
Contacts
Public ContactGaoyi Yang
Hangzhou First People's Hospital
Outcome results
None listed