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

Exclusion criteria

• ✕. Ongoing common cold or flu-like symptoms for 48 hours prior to the screening, including sore throat, blocked nose, runny nose, cough, and sneezing.
• ✕. Participants who experience moderate or severe or higher seasonal allergies, such as hay fever, (symptoms in excess of mild, intermittent nasal rhinorrhea, sneezing, or itchy/watery eyes).
• ✕. Non-therapeutic injection drug use in the 6 months prior to screening and recreational snorting drug use or on prescription medication/ concomitant therapy other than for contraception and antibiotics. Those excluded will include individuals taking prescription medications like systemic steroids, intranasal medicines, among others.
• ✕. Participants who are current smokers.
• ✕. Known allergy to methylparaben, or propylparaben, or any ingredients of the formulated drug product.
• ✕. Use of systemic immunomodulatory medications (Thalidomide, Lenalidomide, Pomalidomide, Imiquimod, etc.), anticoagulants, and other drugs assessed by the site Investigator within the 4 weeks prior to study enrollment.
• ✕. History of alcohol/ substance abuse within 6 months of study enrollment.
• ✕. History of any vaccinations within the 2 weeks prior to enrollment.