FHND1002

Primary Objective: To evaluate the efficacy of FHND1002 in patients with ALS after 48 weeks of treatment. The primary outcome measure was the change in ALSFRS-R scores at 48 weeks. Secondary Objectives: 1) To evaluate other efficacy measures of FHND1002 in patients with ALS, including: a) Efficacy based on change in ALSFRS-R scores at 12, 24, and 36 weeks of treatment; b) Efficacy based on Rasch Global Disability Rating Scale (ROADS), forced vital capacity (FVC%), and Amyotrophic Lateral Sclerosis Assessment Questionnaire-5 (ALSAQ-5) at 12, 24, 36, and 48 weeks of treatment; c) Efficacy based on endpoints (persistent ventilator dependence; tracheotomy; death) at 12, 24, 36, and 48 weeks of treatment; d) Efficacy based on the Composite Assessment of Function and Survival (CAFS) score at 12, 24, 36, and 48 weeks of treatment. 2) Evaluate the safety of FHND1002 in ALS patients. 3) Evaluate the pharmacokinetic parameters of FHND1002 in ALS patients. Exploratory Objectives: Conduct an exploratory biomarker study: Changes in plasma NfL.