Created at Source Raw Value Validated value
Jan. 8, 2021, 12:45 a.m. oms

1. Prior or ongoing medical condition, medical history, physical findings or laboratory abnormality that, in the Investigator’s (or delegate’s) opinion, could adversely affect the safety of the participant. 2. Abnormal and/or clinically significant findings upon examination of the nasal cavity . 3. Has received an investigational drug, other investigational device, or approved therapy for investigational use within 30 days or 5 half-lives of the drug, whichever is longer, prior to screening. 4. Pregnant or breastfeeding. 5. Fever (body temperature >=38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening. 6. Known allergy to SPL7013 or any of the spray components 7. Participant has used any kind of nasal product within 7 days prior to the start of the investigation, and/or the use of nasal products during the investigation is anticipated.

1. Prior or ongoing medical condition, medical history, physical findings or laboratory abnormality that, in the Investigator’s (or delegate’s) opinion, could adversely affect the safety of the participant. 2. Abnormal and/or clinically significant findings upon examination of the nasal cavity . 3. Has received an investigational drug, other investigational device, or approved therapy for investigational use within 30 days or 5 half-lives of the drug, whichever is longer, prior to screening. 4. Pregnant or breastfeeding. 5. Fever (body temperature >=38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening. 6. Known allergy to SPL7013 or any of the spray components 7. Participant has used any kind of nasal product within 7 days prior to the start of the investigation, and/or the use of nasal products during the investigation is anticipated.