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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Respiratory Tract Infections

Intervention / Treatment
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* Device: RD19


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RD19 Experimental Device<br>RD19 Experimental Device used twice/day for 3 minutes each use at least 4 hours, and preferably 8-12 hours, apart | Device: RD19<br>* Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute safety and tolerability | Frequency, grade and attribution of solicited and unsolicited local and systemic Adverse Events (AEs) during the 14 day study period. Solicited AEs: anticipated local and systemic AEs for which consistent collection of information is desired. For this study, solicited AEs include: Oropharyngeal Site Pain Oropharyngeal Site Erythema Oropharyngeal Site Edema/Induration Headache Difficulty swallowing Nausea Fever Chills Unsolicited Adverse Events: All AEs spontaneously reported by the subject and/or in response to an open question from study staff or revealed by observation, physical examination or other diagnostic procedure. Unsolicited AEs of all severities will be reported from the time of study device administration through study termination. Frequency and attribution of any incident Serious Adverse Events during the 14 day study period. | 14 consecutive days of RD19 device use per protocol | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 14 consecutive days of RD19 device use per protocol |