Created at Source Raw Value Validated value
Oct. 29, 2020, 11:45 p.m. oms

1. Participant must be a healthy, adult volunteers, 18-50 years of age, inclusive at Screening. 2. Participant must test negative for influenza, and SARS-CoV-2 by RT-PCR at Screening and should be performed no more than 1 week prior to dosing. 3. Participant must be willing and able to provide written informed consent. 4. Participant must be a nonsmoker, nontobacco user and non-nicotine product user or a former smoker/user. (has not smoked, vaped or used tobacco/nicotine products in the 6 months prior to dosing). 5. Participant must have a Body Mass Index (BMI) more than or equal to 18.0 kg/M2 and less than or equal to 30.0 kg/M2 6. Female participants must be of non-childbearing potential or using a medically acceptable contraceptive regimen from Screening until 30 days post-dose. 7. Male participants must be surgically sterile or using a medically acceptable contraceptive regimen, from screening until 90 days post-dose. 8. Participant must be willing and able to comply with the study schedule, restrictions, and requirements.

1. Participant must be a healthy, adult volunteers, 18-50 years of age, inclusive at Screening. 2. Participant must test negative for influenza, and SARS-CoV-2 by RT-PCR at Screening and should be performed no more than 1 week prior to dosing. 3. Participant must be willing and able to provide written informed consent. 4. Participant must be a nonsmoker, nontobacco user and non-nicotine product user or a former smoker/user. (has not smoked, vaped or used tobacco/nicotine products in the 6 months prior to dosing). 5. Participant must have a Body Mass Index (BMI) more than or equal to 18.0 kg/M2 and less than or equal to 30.0 kg/M2 6. Female participants must be of non-childbearing potential or using a medically acceptable contraceptive regimen from Screening until 30 days post-dose. 7. Male participants must be surgically sterile or using a medically acceptable contraceptive regimen, from screening until 90 days post-dose. 8. Participant must be willing and able to comply with the study schedule, restrictions, and requirements.