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

Primary Purpose

Respiratory Tract Infections

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

RD19

About this trial

This is an interventional prevention trial for Respiratory Tract Infections

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Carolina Phase I

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RD19 Experimental Device

Arm Description

RD19 Experimental Device used twice/day for 3 minutes each use at least 4 hours, and preferably 8-12 hours, apart

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

NCT ID

NCT04557826

First Posted

August 31, 2020

Last Updated

February 3, 2021

Sponsor

KNOWBio Inc.

Collaborators

M3-Wake Research Associates, Carolina Phase I, TAB Clinical

1. Study Identification

Unique Protocol Identification Number

NCT04557826

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

August 31, 2020 (Actual)

Primary Completion Date

September 23, 2020 (Actual)

Study Completion Date

December 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

KNOWBio Inc.

Collaborators

M3-Wake Research Associates, Carolina Phase I, TAB Clinical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Tract Infections

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Open-label

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RD19 Experimental Device

Arm Type

Experimental

Arm Description

RD19 Experimental Device used twice/day for 3 minutes each use at least 4 hours, and preferably 8-12 hours, apart

Intervention Type

Device

Intervention Name(s)

RD19

Intervention Description

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

Primary Outcome Measure Information:

Title

Acute safety and tolerability

Description

Time Frame

14 consecutive days of RD19 device use per protocol

Secondary Outcome Measure Information:

Title

RD19 Acceptability

Description

Time Frame

14 consecutive days of RD19 device use per protocol

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lisa M Cohen, DO

Organizational Affiliation

M3-Wake Research Associates Carolina Phase I

Official's Role

Principal Investigator

Facility Information:

Facility Name

Carolina Phase I

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27612

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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