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

1. Participants with a concomitant disease, disability, or condition which may interfere with the conduct of the study, or which would, in the opinion of the Investigator, pose an unacceptable risk to the participants in this study, including, but not limited to alcohol dependency or abuse, drug dependency or abuse, or previously diagnosed psychiatric disease. 2. Participants who have a history of Bell’s palsy. 3. Participants who give a verbal history of risk factors for SARS-CoV-2 and other common viral respiratory infections including, but not limited to, pre-existing pulmonary disease such as asthma, reactive airway disease, chronic obstructive pulmonary disease, pulmonary hypertension, and emphysema. 4. Participants who give a verbal history of being immunocompromised due to disease or medication (e.g. cancer immunosuppressive therapy), hypertension, coronary artery disease with history of stent or graft, heart failure NYHA class 2 or greater, or diabetes. 5. Participants who have used any prescription medications within 14 days or over-the- counter medications within 7 days before study drug dosing, with the exception of contraceptives for female participants and occasional paracetamol use (at the discretion of the Investigator). 6. Participants who have used vitamins, dietary or herbal supplement, or nutritional supplement within 7 days before study drug dosing. 7. Participant has a history of chronic sinusitis requiring regular use of nasal spray. 8. Participant has had recent nasal surgery or invasive nasal or dental procedure in the preceding 28 days of Day -1. 9. Participant has had active allergic rhinitis within 14 days prior to administration of first dose of Investigational Product. 10. Participant has had administration of systemic antibiotics or antivirals within 7 days prior to Screening (excluding topical/external use of antibiotics). 11. Participant has had major surgery within 30 days of Day -1. 12. Pregnant or breast-feeding women. 13. Participant has received of any immunoglobulins and/or blood products within 3 months of study Screening. 14. Participant has had acute respiratory illness within 30 days prior to administration of first dose of Investigational Product. 15. Participant has used or been administered any intranasal medication or nasal topical treatment within 30 days of Day -1, or plan to use any nasal products during the study. 16. Participant is using systemic corticosteroids including low-dose oral prednisone and any systemic immunomodulatory therapy. 17. Participant has received treatment with any investigational product in any clinical study within 30 days of Day -1 or five half-lives, whichever is longer. 18. Participant has received a vaccination within 30 days of dosing 19. Participant is unwilling or unable to comply with the study protocol requirements.

1. Participants with a concomitant disease, disability, or condition which may interfere with the conduct of the study, or which would, in the opinion of the Investigator, pose an unacceptable risk to the participants in this study, including, but not limited to alcohol dependency or abuse, drug dependency or abuse, or previously diagnosed psychiatric disease. 2. Participants who have a history of Bell’s palsy. 3. Participants who give a verbal history of risk factors for SARS-CoV-2 and other common viral respiratory infections including, but not limited to, pre-existing pulmonary disease such as asthma, reactive airway disease, chronic obstructive pulmonary disease, pulmonary hypertension, and emphysema. 4. Participants who give a verbal history of being immunocompromised due to disease or medication (e.g. cancer immunosuppressive therapy), hypertension, coronary artery disease with history of stent or graft, heart failure NYHA class 2 or greater, or diabetes. 5. Participants who have used any prescription medications within 14 days or over-the- counter medications within 7 days before study drug dosing, with the exception of contraceptives for female participants and occasional paracetamol use (at the discretion of the Investigator). 6. Participants who have used vitamins, dietary or herbal supplement, or nutritional supplement within 7 days before study drug dosing. 7. Participant has a history of chronic sinusitis requiring regular use of nasal spray. 8. Participant has had recent nasal surgery or invasive nasal or dental procedure in the preceding 28 days of Day -1. 9. Participant has had active allergic rhinitis within 14 days prior to administration of first dose of Investigational Product. 10. Participant has had administration of systemic antibiotics or antivirals within 7 days prior to Screening (excluding topical/external use of antibiotics). 11. Participant has had major surgery within 30 days of Day -1. 12. Pregnant or breast-feeding women. 13. Participant has received of any immunoglobulins and/or blood products within 3 months of study Screening. 14. Participant has had acute respiratory illness within 30 days prior to administration of first dose of Investigational Product. 15. Participant has used or been administered any intranasal medication or nasal topical treatment within 30 days of Day -1, or plan to use any nasal products during the study. 16. Participant is using systemic corticosteroids including low-dose oral prednisone and any systemic immunomodulatory therapy. 17. Participant has received treatment with any investigational product in any clinical study within 30 days of Day -1 or five half-lives, whichever is longer. 18. Participant has received a vaccination within 30 days of dosing 19. Participant is unwilling or unable to comply with the study protocol requirements.