FHND1002 for ALS Treatment: Phase 2

Inclusion criteria

• Subjects must be ≥18 years of age at the time of signing the informed consent form.
• Subjects must have a diagnosis of Amyotrophic Lateral Sclerosis (ALS) meeting the revised El Escorial World Federation of Neurology criteria categories including Clinically Definite ALS, Clinically Probable ALS, Laboratory-supported Probable ALS, or Clinically Possible ALS.
• Subjects must demonstrate a documented mean monthly decline of ≥0.5 points in the ALS Functional Rating Scale-Revised (ALSFRS-R) score since initial diagnosis.
• During screening, subjects must exhibit a percent predicted forced vital capacity (FVC%) ≥70%; note that use of non-invasive ventilation (NIV) is exclusionary.
• Disease duration must be ≤2 years calculated from the onset of the first ALS-related symptom.
• At screening, subjects must have an ALSFRS-R total score ≥30 with a swallowing function subscore ≥2 and all respiratory-related subscores at 4 points.
• Subjects must have a Body Mass Index (BMI) ≥18.5 kg/m².
• Subjects may or may not be receiving stable therapeutic doses of approved ALS medications (e.g., edaravone, riluzole) prior to enrollment, provided any existing regimen remains unchanged throughout the study.
• Subjects must demonstrate ability to understand study procedures, willingness to comply, voluntary participation, and provide signed informed consent.

Exclusion criteria

• Subjects with coexisting neurological disorders that may mimic ALS symptoms or interfere with efficacy assessment (e.g., cervical/lumbar spondylosis, dementia, history of seizures except childhood febrile seizures) will be excluded.
• Subjects exhibiting motor conduction block or sensory nerve conduction abnormalities on electromyography (EMG) testing will be excluded.
• Subjects with any history of spinal surgery within 3 months prior to screening will be excluded.
• Subjects showing clinically significant laboratory abnormalities at screening including aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 × upper limit of normal (ULN), or serum creatinine (Scr) > ULN will be excluded.
• Subjects with severe/uncontrolled cardiac, hepatic, renal, hematologic, or neoplastic diseases, or active severe psychiatric disorders will be excluded.
• Exclusion applies to pregnant or lactating women, and subjects planning pregnancy during the study or within 3 months post-treatment; participants of childbearing potential unwilling to use highly effective contraception throughout the study and for 3 months after last dose are excluded.
• Subjects with known or suspected hypersensitivity to FHND1002 or its excipients will be excluded.
• Subjects who have participated in another investigational drug/device trial within 1 month prior to screening will be excluded.
• Subjects deemed by the Investigator to have any condition compromising safety, data integrity, or study compliance will be excluded.