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

NCT04557826 | Completed Results FDA Device

• 1 other identifier: RD19-01-Q320
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Device: RD19

Interventions

RD19 DEVICE

Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens

RD19 Experimental Device

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• EmitBio Inc.: lead

Study Sites (1)

Carolina Phase I

Raleigh, North Carolina, 27612, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Limitations and Caveats

This is a phase I, open-label, safety study and is not designed to test any statistical hypotheses. Rather, this is a descriptive study intended to obtain preliminary estimates in healthy adults of the safety, including reactogenicity, of the EmitBio™ RD19 Device.

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: EmitBio

info@emitbio.com

919-321-1734

Study Officials

• Lisa M Cohen, DO

  M3-Wake Research Associates Carolina Phase I

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open-label

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: September 22, 2020
• Study Start: August 31, 2020
• Primary Completion: September 23, 2020
• Study Completion: December 7, 2020
• Last Updated: October 3, 2024
• Results First Posted: October 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)