TP04HN106 in the Treatment of Patients With Amyotrophic Lateral Sclerosis

1. Meet the diagnostic criteria for amyotrophic lateral sclerosis (ALS) (Gold Coast Criteria 2020）;

2. Age ≥18 years old, male or female;

3. The amyotrophic lateral sclerosis Function Rating Scale (ALSFRS-R）of pre-visit subjects should be ≥1 score for dyspnea, upright breathing and respiratory dysfunction;

4. Pre-randomized subjects received stable dose of riluzole tablets for ≥7 days, and should maintain the treatment until the last study visit;

5. Voluntarily participate in clinical trials, sign informed consent, and understand and comply with study procedures.

1. The subject is known to be allergic to the investigational drug or its excipients;

2. The subject has a disease or injury that interferes with functional assessment or threatens life, or is accompanied by a serious irreversible disease of the heart, lung, liver, or brain, or is accompanied by a failure of different organs (for patients with respiratory failure, only patients diagnosed as type I or type II respiratory failure are excluded);

3. The subject has a major mental illness or cognitive dysfunction;

4. Patients with a history of secondary or above surgery within one month before the screening period;

5. The subjects participated in other clinical studies within 1 month;

6. The subjects are pregnant or lactating women;

7. Poor compliance or other researchers believe that there are any circumstances that are not suitable for inclusion.