The Study of Safety and Preliminary Efficacy of Aleeto in Patients With Amyotrophic Lateral Sclerosis

Trial ID: NCT06181526

Interventional - Phase 1 - Unknown status

This study is a single-center, randomized, double-blind, placebo parallel-controlled, dose-escalation clinical study. The aim of this study was to evaluate the safety, tolerability, and preliminary effect of Aleeto in adult patients with ALS, and to provide an appropriate dose for the future clinical trial.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

• Aleeto
• intravenous injection
• intrathecal injection

Eligibility

Inclusion criteria

• 1. Subjects who are qualified for the clinical trial program cycle judged by well-trained physicians;
• 2. 18 years old≤ age≤ 75 years old, males or females;
• 3. Forced vital capacity ≥ 80% of predicted vital capacity during the screening period;
• 4. The total score of the ALSFRS-R scale ≥ 30 points and ≤40 points during enrollment, and the respiratory function item ≥ 3 points;
• 5. Diagnosis of confirmed or probable ALS in accordance with the revised EI Escorial diagnostic criteria for amyotrophic lateral sclerosis of the World Federation of Neurology;
• 6. Subjects or their legal representatives clearly understand and voluntarily participate in the study and sign the informed consent form;
• 7. Subjects (including male subjects) are willing to have no birth plan and voluntarily take effective contraceptive measures during the entire study period and within 3 months after the end of the study, and have no plan to donate sperm or eggs.

Exclusion criteria

• 1. Diagnosed with familial ALS (based on family history);
• 2. With obvious cognitive impairment (MMSE scale: ≤19 points in the illiteracy group，≤ 22 points in the primary school group, and ≤26 points in the junior high school group (more than 8 years of education);
• 3. Obvious dysphagia;
• 4. Positive HIV test or history of positive test;
• 5. Positive hepatitis C virus antibody or positive test history;
• 6. Hepatitis B active infection (hepatitis B surface antigen positive and/or serum HBV DNA positive or serum HBV DNA \> 2 × 108 IU/ml;
• 7. Have used other investigational drugs within 1 month or within 5 drug half-lives;
• 8. Diseases and deformities of the lumbar spine;
• 9. Have other conditions known to be associated with motor neuron dysfunction that may confuse or obscure an ALS diagnosis;
• 10. Other psychiatric disorders diagnosed according to DSM-V diagnostic criteria, or significant suicide intent;
• 11. With severe hepatic insufficiency, renal insufficiency or severe cardiac insufficiency (severe hepatic insufficiency refers to ALT value≥2.0 times the upper limit of normal value or AST value≥2.0 times the upper limit of normal value; severe renal insufficiency refers to CRE≥1.5 times the upper limit of normal value or eGFR\<40mL/min/1.73m2; severe cardiac insufficiency refers to NYHA class 3-4);
• 12. Permanently dependent on ventilator-assisted ventilation;
• 13. History of alcohol and drug abuse; Edaravone users;
• 14. Patients who are pregnant, breast-feeding, or who are likely to become pregnant and plan to become pregnant;
• 15. Patients participating in other clinical trials or using other biological agents, drugs, or devices under investigation;
• 16. Patients who have received any vaccinations within 28 days;
• 17. Contraindications to MRI (eg, claustrophobia);
• 18. Unable to be cooperative and complete the follow-up due to other reasons.

Sponsor

Beijing Tiantan Hospital

Source: ClinicalTrials.gov

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