Respiratory Tract Infections Clinical Trial
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
Verified date | February 2021 |
Source | KNOWBio Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | December 7, 2020 |
Est. primary completion date | September 23, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Provides written informed consent prior to initiation of any study 2. Agrees to comply with planned study procedures and be available for all study visits. 3. Agrees to the collection of venous blood per protocol. 4. Male or non-pregnant female, 18 to 45 years of age, inclusive, at time of enrollment. 5. Body Mass Index 18-35 kg/m2, inclusive, at screening. 6. Woman of childbearing potential must have a negative urine pregnancy test within 7 days prior to study initiation. 7. Oral temperature is less than 100.0°F (37.8°C). 8. Pulse no greater than 90 beats per minute. 9. Systolic BP is 85 to 150 mmHg and Diastolic BP = 90 mmHg, inclusive. 10. Clinical screening laboratory evaluations are within acceptable normal reference ranges at the clinical laboratory being used. Exclusion Criteria: 1. Positive urine pregnancy test at screening. 2. Has any medical disease or condition that, in the opinion of the site PI or appropriate sub- investigator, precludes study participation. 3. 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. 4. Presence of self-reported or medically documented significant medical or psychiatric condition(s). 5. 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. 6. Reports a recent positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV-1 antibodies at screening. 7. Currently enrolled in or plans to participate in another clinical trial with an interventional investigational agent that will be received during the study period. 8. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to nitrates, nitrites or sun exposure. 9. Active use of any medications that may be associated with pharyngeal or oral mucosal irritation. 10. Has any blood dyscrasias or significant disorder of coagulation. 11. Has a history of alcohol abuse or other recreational drug (excluding cannabis) use within 1 month of Study Day 1. 12. 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. |
Country | Name | City | State |
---|---|---|---|
United States | Carolina Phase I | Raleigh | North Carolina |
Lead Sponsor | Collaborator |
---|---|
KNOWBio Inc. | Carolina Phase I, M3-Wake Research Associates, TAB Clinical |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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