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

Completed · Not applicable

Conditions studied: Respiratory Tract Infections

In brief

This first-in-man (FIM) phase I study will evaluate the acute safety, tolerability, and acceptability of the investigational RD19 device among 25 healthy volunteers between the age of 18 and 45.

Key facts

Study ID

NCT04557826

Run by

EmitBio Inc.

People needed

25

Starts

2020-08-31

Expected to finish

2020-12-07

Last updated by the study team

2024-10-03

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Carolina Phase I — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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