Clinical Research Directory

Key Inclusion Criteria: * An informed consent signed and dated by the participant. * 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 kg/m2 to ≤ 32 kg/m2. * No course of medication, whether prescribed or over the counter, in the 4 weeks before study drug administration. * Both males and females of childbearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards. * Not a current smoker (or regular user of any nicotine containing product). * Willing to follow all study rules. Key Exclusion Criteria: * Women who are pregnant or nursing. * History of anaphylaxis, food allergies, or allergies (chronic or seasonal) requiring prescription medication. * History of asthma requiring the use of inhaled medication within the past 5 years. * Vaccination within 4 weeks prior to study drug administration (subjects must agree to avoid vaccination during the study). * Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to Screening. * Positive urine test for alcohol and drugs of abuse. Additional protocol defined inclusion and exclusion criteria could apply.