Open-label Study to Evaluate Safety, Tolerability and PK of BHV-0223 in ALS

Exclusion Criteria

• •1. Target Disease Exceptions
• •2. Medical History Exceptions
• •1. Subject is known to have a current diagnosis of acute or chronic viral hepatitis;
• •2. Subject is known to have any other acute or chronic liver disease that is clinically significant in the investigator's judgment;
• •3. Subject has a history of a clinically significant medical condition that would interfere with the subject's ability to comply with study instructions, would place the subject at increased risk, or might confound the interpretation of the study results in the investigator's judgment;
• •4. Any other sound medical, psychiatric and/or social reason in the investigator's judgment;
• •3. Physical and Laboratory Test Findings
• •1. Positive urine pregnancy test in WOCBP at screening;
• •2. Subject has evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or other determinations beyond what is consistent with the target population, in the investigator's judgment;
• •3. Subject has liver function testing abnormalities (ALT, AST , or total bilirubin) that are \> 1 x ULN;
• •4. Other Exclusions a. Subjects who are unable to be compliant with the visit schedule or protocol procedures.