Respiratory Tract InfectionsNCT04557826
Acute Safety and Acceptability Study of Experimental Device RD19 for Protection From Human Respiratory Disease Pathogens
A study testing RD19 in people with Respiratory Tract Infections, run by EmitBio Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections
- What is being tested?
- RD19
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 7 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Open-label, First-in-Man Acute Safety, Tolerability and Device Acceptability Study of Experimental Device RD19 for Protection From Human Respiratory Tract Pathogens
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.
Read the detailed description
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. Based on the results of numerous preclinical studies, a short 3 minute use twice a day, separated by at least 4 hours, preferably 8 to 12 hours apart) will be evaluated.
Safety and tolerability (local reactogenicity) will be assessed actively at the following study days: screening (baseline set), 1, 7 and 14, and on non-clinic visit days by collection of these data by history during clinic visits via a memory aid (diary cards). Volunteers will be encouraged to promptly contact designated clinical trial staff or the one of the Sponsor's Emergency Response Team for AEs of a medically urgent nature.
A Comprehensive Metabolic Panel, as well as CBC with differential, urinalysis, and pregnancy testing will be performed at screening and at Day 14 or early termination (and potentially during unscheduled) clinic visits. Hematological safety assessments (evaluation of methemoglobinemia) will be performed at all visits.
Study volunteers will be asked to immediately contact the clinical coordinator and/or the PI in all instances where they experience an AE of greater than moderate intensity. Volunteers will be instructed to report to the clinical trial unit for an unscheduled visit or to seek the appropriate level of medical care based on the nature of their AE/SAE. In all such instances, all relevant information pertaining to these significant medical events will be captured on the appropriate e-CRFs.
Hematology safety laboratory evaluations will be performed at screening, as well during all scheduled clinic visits. Laboratory assessments may be part of the evaluation of medically attended AE evaluation and for all SAEs.
Upon ratification of the CTA, the site began pre-recruitment outreach efforts of potential volunteers within M3-WRA's database to ascertain "interest in general" in this study. Official recruitment which may include fliers, letters, telephone calls, etc. and specific recruitment of potential subjects who have previously participated in other clinical studies conducted at the site commenced only after formal IRB approval. Other forms and/or mechanisms of recruitment may also be used. The IRB will approved the recruitment process and all materials prior to use.
- Conditions
- Respiratory Tract Infections
- Being tested
- RD19
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RD19Device
Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens
| Study group | Role | What they receive |
|---|---|---|
| RD19 Experimental Device | Experimental | RD19 Experimental Device used twice/day for 3 minutes each use at least 4 hours, and preferably 8-12 hours, apart Receives: Device: RD19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
RD19 Acceptability
- Ease of device use (Likert Scale 1 -10)
- Clarity of user instructions (Likert Scale 1-10)
- Compliance with per protocol schedule (# times missed / 28) and, if out of compliance, reason(s) for noncompliance (collected as verbal string).
Measured: 14 consecutive days of RD19 device use per protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start31 Aug 2020
- Primary completion23 Sep 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-label
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- EmitBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa M Cohen, DO, Principal investigator, M3-Wake Research Associates Carolina Phase I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557826
- Sponsor's protocol ID
- RD19-01-Q320
- Status last verified
- Sep 2024
- First submitted
- 31 Aug 2020
- Last updated
- 3 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label, First-in-Man Acute Safety, Tolerability and Device Acceptability Study of Experimental Device RD19 for Protection From Human Respiratory Tract Pathogens
- ClinicalTrials.gov ID
- NCT04557826
- Acronym / sponsor ID
- RD19-01-Q320
- Conditions
- Respiratory Tract Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- EmitBio Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 23 Sep 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Posted 3 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Based on the results of numerous preclinical studies, a short 3 minute use twice a day, separated by at least 4 hours, preferably 8 to 12 hours apart) will be evaluated.
Safety and tolerability (local reactogenicity) will be assessed actively at the following study days: screening (baseline set), 1, 7 and 14, and on non-clinic visit days by collection of these data by history during clinic visits via a memory aid (diary cards). Volunteers will be encouraged to promptly contact designated clinical trial staff or the one of the Sponsor's Emergency Response Team for AEs of a medically urgent nature.
A Comprehensive Metabolic Panel, as well as CBC with differential, urinalysis, and pregnancy testing will be performed at screening and at Day 14 or early termination (and potentially during unscheduled) clinic visits. Hematological safety assessments (evaluation of methemoglobinemia) will be performed at all visits.
Study volunteers will be asked to immediately contact the clinical coordinator and/or the PI in all instances where they experience an AE of greater than moderate intensity. Volunteers will be instructed to report to the clinical trial unit for an unscheduled visit or to seek the appropriate level of medical care based on the nature of their AE/SAE. In all such instances, all relevant information pertaining to these significant medical events will be captured on the appropriate e-CRFs.
Hematology safety laboratory evaluations will be performed at screening, as well during all scheduled clinic visits. Laboratory assessments may be part of the evaluation of medically attended AE evaluation and for all SAEs.
Upon ratification of the CTA, the site began pre-recruitment outreach efforts of potential volunteers within M3-WRA's database to ascertain "interest in general" in this study. Official recruitment which may include fliers, letters, telephone calls, etc. and specific recruitment of potential subjects who have previously participated in other clinical studies conducted at the site commenced only after formal IRB approval. Other forms and/or mechanisms of recruitment may also be used. The IRB will approved the recruitment process and all materials prior to use.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-label
| Arm | Type | Receives |
|---|---|---|
| RD19 Experimental Device | Experimental | Device: RD19RD19 Experimental Device used twice/day for 3 minutes each use at least 4 hours, and preferably 8-12 hours, apart |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RD19Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens | Device | RD19 Experimental Device |
Primary outcome
RD19 Acceptability
Time frame: 14 consecutive days of RD19 device use per protocol
* Ease of device use (Likert Scale 1 -10) * Clarity of user instructions (Likert Scale 1-10) * Compliance with per protocol schedule (# times missed / 28) and, if out of compliance, reason(s) for noncompliance (collected as verbal string).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa M Cohen, DO principal investigator
M3-Wake Research Associates Carolina Phase I
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RD19 in people with Respiratory Tract Infections, run by EmitBio Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RD19 Acceptability (time frame: 14 consecutive days of RD19 device use per protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.