Acute Safety and Acceptability Study of Experimental Device RD19 for Protection From Human Respir… (NCT04557826) | Clinical Trial Compass
CompletedNot Applicable
Acute Safety and Acceptability Study of Experimental Device RD19 for Protection From Human Respiratory Disease Pathogens
United States25 participantsStarted 2020-08-31
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
RD19 Acceptability
Timeframe: 14 consecutive days of RD19 device use per protocol
. 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.