This is the first-in-human clinical study to see if a single dose of an investigational nasal spray made from a modified plant protein called Q-Griffithsin is safe, tolerated and acceptable for use by healthy adults 18 to 60 years of age.
Q-Griffithsin (Q-GRFT) nasal spray is an investigational product that has broad spectrum antiviral activity. Q-GRFT is derived from Griffithsin (GRFT) a naturally occurring protein originally isolated from the red alga Griffithsia found in the South Pacific Ocean. For the purposes of this study GRFT has been genetically modified to produce a more stable compound less prone to oxidation, Q-GRFT. Q-GRFT is under study for potential therapeutic applications against several viral pathogens including HIV, herpes simplex virus type-2, and hepatitis C Q-GRFT suppresses replication of many different coronaviruses, including coronaviruses that cause the common cold, as well as Middle East Respiratory Syndrome Coronavirus (MERS-CoV) and Severe Acute Respiratory Syndrome Coronavirus type-1 (SARS-CoV) as well as Severe Acute Respiratory Syndrome Coronavirus type-2 (SARS-CoV-2). The investigational product is a nasal spray containing Q-GRFT, and other excipients designed to optimize delivery of Q-GRFT to the nasal and naso-pharyngeal mucosa, where SARS-CoV-2 often first initiates infection. Up to 18 healthy individuals between the ages of 18 and 60 years will be enrolled at the University of Louisville. Participants will be assigned 2:1 In a randomized and blinded fashion to receive either the Q-GRFT nasal spray or a placebo nasal spray. Participants in this study will have screening procedures including lab tests and health questions. If they are eligible for the study, they will have blood drawn for additional lab tests, have an examination of their nasal cavity by a doctor using a scope, and have nasal and throat mucus samples collected. There will be one dose of a nasal spray after the participant is randomized to their respective group. Samples will be collected at 1, 6, and 24 hours as well as 3 days after the nasal spray dose. The participant will answer questions about their quality of life, medical history and current medical status, and their experience with the study treatment. Their COVID-19 antibodies will also be checked, and they will be informed of the results. This is a phase 1 trial. The first human tests of investigational drugs or therapies occur in Phase 1 trials. Phase 1 trials are designed to determine the best dose of the study drug and to check for any potential side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
18
intranasal spray administered as a single dose
intranasal spray administered as a single dose
University of Louisville
Louisville, Kentucky, United States
The safety of a single exposure of Q-GRFT study product (SP) will be evaluated when administered via a nasal spray system.
Incidence of AEs Grade 3 or higher as defined by the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events V2.1 (July 2017) will be used to determine whether the product is safe. Any emergent AEs will be discussed with the Safety Committee. All serious adverse events will be reported by the site investigator(s) to the Medical Monitor and IND Sponsor/Protocol Chair within 24 hours of the site becoming aware of the event.
Time frame: 3 Weeks
The product acceptability will be assessed to determine its use by the participants
The acceptability questionnaire will be filled out by the participants and provide participants' opinions on the spray characteristics, administration process, the applicator/spray design, and the use regimen, as well as the degree to which participants believe these characteristics and side-effects could pose barriers in future sustained use. The proportion of participants who report product characteristics to be considered a barrier in use, operationalized as having a rating of lower than 3 on a 5-point Likert scale, in disliking or likelihood of future barrier in use will be calculated and examined.
Time frame: 3 Weeks
Pharmacokinetics of the product
Q-GRFT Study Product (SP) concentration will be assessed in plasma, nasal, nasopharyngeal, and oropharyngeal fluids.
Time frame: 3 Weeks
Smell assessment will be performed to evaluate the impact of Q-GRFT SP intranasal treatment on the sensation using the University of Pennsylvania Brief Smell Identification Test (BSIT), a validated assessment of olfactory function [1].
The BSIT assesses an individual's ability to detect odors at a suprathreshold level. The test consists of 12 items provided in a 12-page booklet. On each page, there is a "scratch and sniff" strip embedded with a microencapsulated odorant along with 4 choice options. The scents are released by scratching the surface with a pencil, after which the participant smells the strip and chooses the odor from the four choices listed \[2\]. Scores range from 0-12. The BSIT has demonstrated good reliability (r=.71) and takes less than 5 minutes to complete. 1. Doty, R.L., A. Marcus, and W. William Lee, Development of the 12-item cross-cultural smell identification test (CC-SIT). The Laryngoscope, 1996. 106(3): p. 353-356. 2. Doty, R.L., Office procedures for quantitative assessment of olfactory function. Am J Rhinol, 2007. 21(4): p. 460-73.
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Time frame: 3 Weeks
Subject quality of Life (12-Item Short Form Survey (SF-12))
will be evaluated with the SF-12 battery of questions. Scores range from 0-100, with higher scores indicating better physical and mental health functioning.
Time frame: 3 Weeks