FHND1002 for ALS Treatment: Phase 2

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.