Safety, Tolerability, and Pharmacokinetics of Q-Griffithsin Intranasal Spray

Inclusion Criteria:

• COVID-19 negative using Rapid antigen test at screening.
• Able and willing to provide written informed consent to take part in the study.
• Able and willing to provide adequate information for locator purposes.
• Availability to return for all study visits, barring unforeseen circumstances.
• Agree not to participate in other research studies involving drugs and/or medicaldevices during the study period.
• Female participants must meet the following criteria: Postmenopausal or using (or willing to use) an acceptable form of contraception (e.g.,barrier method, IUD, hormonal contraception, sexual abstinence, surgical sterilization, orvasectomization of male partner). If the female participant has female partners only, the method of contraception will benoted as a barrier method for study documentation. Not be pregnant at the baseline or enrollment visit. Not be breastfeeding at screening orintend to breastfeed during study participation per participant report.
• Willingness and ability to defer vaccinations until after study participation iscompleted. This does not include COVID-19 vaccinations.
• Participants should have received all COVID-19 vaccines that they are eligible for.Those eligible for booster doses will not delay getting their dose for purposes ofenrolling in the study. They will first obtain their booster dose and be re-evaluatedfor enrollment 2 weeks following their booster dose.
• Willingness to perform at-home study product self-administration according to writteninstructions that will be provided.
• Willingness to follow local guidelines for mask-wearing and face coverings.
• Must be in general good health in the opinion of the investigator.

Exclusion Criteria:

• Participants with ongoing moderate to severe allergic rhinitis, asthma, or history ofchronic obstructive pulmonary disease (COPD), and currently suffering from chronicrhinitis or acute/chronic sinusitis.
• Participants who report any of the following at Screening:

1. Ongoing common cold or flu-like symptoms for 48 hours prior to the screening,including sore throat, blocked nose, runny nose, cough, and sneezing.
2. Participants who experience moderate or severe or higher seasonal allergies, suchas hay fever, (symptoms in excess of mild, intermittent nasal rhinorrhea,sneezing, or itchy/watery eyes).
3. Non-therapeutic injection drug use in the 6 months prior to screening andrecreational snorting drug use or on prescription medication/ concomitant therapyother than for contraception and antibiotics. Those excluded will includeindividuals taking prescription medications like systemic steroids, intranasalmedicines, among others.
4. Participants who are current smokers.
5. Known allergy to methylparaben, or propylparaben, or any ingredients of theformulated drug product.
6. Use of systemic immunomodulatory medications (Thalidomide, Lenalidomide,Pomalidomide, Imiquimod, etc.), anticoagulants, and other drugs assessed by thesite Investigator within the 4 weeks prior to study enrollment.
7. History of alcohol/ substance abuse within 6 months of study enrollment.
8. History of any vaccinations within the 2 weeks prior to enrollment.
9. Participating in another research study involving drugs or medical devices withinthe 4 weeks prior to enrollment.
10. Having plans to relocate away from the study site area during the period of studyparticipation.

• Has any of the following laboratory abnormalities at Screening:

1. White blood cell count < 2,000 cells/mm3 or > 15,000 cells/mm3.
2. Hemoglobin <12 g/dL for men and <11 g/dL for women.
3. Calculated creatinine clearance >1.1 x upper limit of normal (ULN).
4. Alanine transaminase (ALT) and/or aspartate aminotransferase (AST) > 1.1 × thesite laboratory ULN.
5. Total bilirubin > 1.1 x ULN.
6. ≥ +1 glucose or +2 protein on urinalysis (UA).

• Any other condition or prior therapy that, in the opinion of the investigator, wouldpreclude informed consent, make study participation unsafe, make the individualunsuitable for the study, or unable to comply with the study requirements. Suchconditions may include but are not limited to a current or recent history (within last 6 months) of severe, progressive, or uncontrolled substance abuse, or renal, hepatic,hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral disease,severe nasal septum deviation, or other condition that may cause nasal obstructionlike nasal polyps or nasal/ sinus surgery in the past.