Key Inclusion Criteria:  Understand and agree to comply with the study procedures and provide written informed consent  Key Exclusion Criteria:  Has received any investigational product (for example, study drug, biologic, device) within 30 days or 5 elimination half-lives, whichever is longer Pregnant or lactating women Men and women of childbearing potential without effective contraception during the study Has any lab abnormalities or clinically significant medical condition that could interfere with the interpretation of study results or limit the participant's enrollment