The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of oral SEP-631 in healthy adult volunteers.

Inclusion Criteria:

1. Subjects who are able and willing to provide informed consent
2. Aged 18 to 60 years at the time of consent
3. Have a BMI within the range 18.5 to 32.0 kg/m2
4. In general good health

Exclusion Criteria:

1. Any condition, which in the investigator's opinion might jeopardize participant's safety or compliance with the protocol.
2. Have a history of any severe allergic reaction or anaphylaxis
3. Have clinically significant abnormalities on clinical laboratory results.
4. Participation in other clinical trials recently/currently