A Study to Evaluate Single and Multiple Doses of SEP-631 in Healthy Adult Volunteers

A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of SEP-631 in Healthy Adult Volunteers

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