Acute Safety and Acceptability Study of Experimental Device RD19 for Protection From Human Respiratory Disease Pathogens

Inclusion Criteria

• Provides written informed consent prior to initiation of any study
• Agrees to comply with planned study procedures and be available for all study visits.
• Agrees to the collection of venous blood per protocol.
• Male or non-pregnant female, 18 to 45 years of age, inclusive, at time of enrollment.
• Body Mass Index 18-35 kg/m2, inclusive, at screening.
• Woman of childbearing potential must have a negative urine pregnancy test within 7 days prior to study initiation.
• Oral temperature is less than 100.0°F (37.8°C).
• Pulse no greater than 90 beats per minute.
• Systolic BP is 85 to 150 mmHg and Diastolic BP ≤ 90 mmHg, inclusive.
• Clinical screening laboratory evaluations are within acceptable normal reference ranges at the clinical laboratory being used.

Exclusion Criteria

• Positive urine pregnancy test at screening.
• Has any medical disease or condition that, in the opinion of the site PI or appropriate sub- investigator, precludes study participation.
• Plans to travel away from the study site area during the term of study to a location or in a manner that may interfere with full completion of the study per protocol.
• Presence of self-reported or medically documented significant medical or psychiatric condition(s).
• Has an acute illness, as determined by the site PI or appropriate sub-investigator, with or without fever [oral temperature >37.8°C (100.0°F)] within 72 hours of study day 1.
• Reports a recent positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV-1 antibodies at screening.
• Currently enrolled in or plans to participate in another clinical trial with an interventional investigational agent that will be received during the study period.
• Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to nitrates, nitrites or sun exposure.
• Active use of any medications that may be associated with pharyngeal or oral mucosal irritation.
• Has any blood dyscrasias or significant disorder of coagulation.
• Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 1 month of Study Day 1.
• Has any oral abnormality that would interfere with device use, or intra-oral metal body piercings that cannot be removed for the duration of the study. Metal orthodontia is permitted as braces will be covered by the device mouthpiece.