Acute Safety and Acceptability Study of Experimental Device RD19 for Protection From Human Respiratory Disease Pathogens
Condition: Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional

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.
    

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.
    

Intervention name(s): RD19
Intervention type(s): Device
Intervention description(s): Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens
Intervention model: Single Group Assignment
Intervention model description: Open-label
Masking: None (Open Label)
Primary purpose: Prevention