HEALEY ALS Platform Trial - Regimen I NUZ-001

The HEALEY ALS Platform Trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of ALS. Regimen I will evaluate the safety and efficacy of a single study drug, NUZ-001, in participants with ALS.

Inclusion Criteria: * No additional inclusion criteria beyond the inclusion criteria specified in the Master Protocol (NCT NCT04297683). Exclusion Criteria: * The following exclusion criteria are in addition to the exclusion criteria specified in the Master Protocol (NCT NCT04297683). 1. Clinically significant liver disease (e.g., chronic hepatitis B, untreated hepatitis C) 2. Prior history of drug-induced liver injury (DILI) and/or laboratory results at Master Protocol Screening that indicate inadequate liver function (ALT, AST or alkaline phosphatase \>3 times the upper limit of normal \[x ULN\] and/or total bilirubin level \>2 x ULN) a. Note: Elevated total bilirubin attributable to documented Gilbert's syndrome is not considered exclusionary when there is no other evidence of clinically significant hepatic dysfunction. 3. Family history of SOD1 or VCP-associated ALS or known SOD1 or VCP mutation via genetic testing or self-report 4. Use of any prohibited medications as outlined in the Regimen-specific Appendix (RSA) within 30 days prior to Baseline or anticipated use during the study treatment period 5. Participants who are taking Nuedexta® and have a prolonged Fridericia-corrected QT (QTcF) interval (QTcF \> 450 ms (males) or \> 470 ms (females)) at Master Protocol Screening