Created at Source Raw Value Validated value
April 30, 2021, 1:45 a.m. oms

a. Female participants must be of non-childbearing potential, or, b. If of childbearing potential, be non-pregnant or lactating and agree to use highly effective contraception from screening through 30 days post- dose. c. Male participants, if not surgically sterilized and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 90 days post-dose and agree not to donate sperm during this period. 3. Is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the screening visit and/or before the first dose of study drug. 4. Weigh at least 45 kg at the time of screening 5. Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 at the time of screening 6. Negative SARS-CoV2 test per site standards 7. Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments 8. Willing to refrain from over-the-counter or prescription medications or herbal, nutritional or dietary supplements from 7 days before first dose through the end of study. 9. Willing to refrain from alcohol and caffeine from 48 hours before first dose through the last dose of study drug 10. Subjects who smoke no more than 2 cigarettes or equivalent per week can be included in the study but must be willing to abstain from smoking during the confinement period. 11. Willing and able to provide written informed consent

a. Female participants must be of non-childbearing potential, or, b. If of childbearing potential, be non-pregnant or lactating and agree to use highly effective contraception from screening through 30 days post- dose. c. Male participants, if not surgically sterilized and if engaging in sexual intercourse with a female partner of childbearing potential, must be willing to use highly effective contraception from screening through 90 days post-dose and agree not to donate sperm during this period. 3. Is judged to be in good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests performed at the screening visit and/or before the first dose of study drug. 4. Weigh at least 45 kg at the time of screening 5. Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 at the time of screening 6. Negative SARS-CoV2 test per site standards 7. Agrees to be available for all study visits and cooperate fully with the requirements of the study protocol, including the schedule of assessments 8. Willing to refrain from over-the-counter or prescription medications or herbal, nutritional or dietary supplements from 7 days before first dose through the end of study. 9. Willing to refrain from alcohol and caffeine from 48 hours before first dose through the last dose of study drug 10. Subjects who smoke no more than 2 cigarettes or equivalent per week can be included in the study but must be willing to abstain from smoking during the confinement period. 11. Willing and able to provide written informed consent