Key Inclusion Criteria:  An informed consent signed and dated by the subject. Healthy volunteer aged 18-55. In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results. Body mass index (BMI) ≥ 18.5 kg/m2 to ≤ 35 kg/m2 No medication other than mild analgesics, vitamins and mineral supplements or, oral contraceptives. Both males and females of child bearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards. Not a current smoker, vaper, or regular user of any nicotine or cannabinoid containing products Willing to follow all study rules  Key Exclusion Criteria:  Women who are pregnant or nursing History of anaphylaxis or systemic reactions to food or other triggers Autoimmune disorders requiring more than topical medication Vaccination with live vaccines within 4 months prior to screening visit (subjects must agree to avoid live vaccination during the study and 4 months after). Positive urine test for alcohol and drugs of abuse.  Other Protocol defined inclusion and exclusion criteria could apply.