This is a phase I randomized, placebo-controlled, single site to assess the local and
systemic safety of intranasal Q-Griffithsin (Q-GRFT) after 14 doses in approximately 45 adult
participants. Participants will be randomized 2:1 (Q-GRFT nasal spray: placebo nasal spray)
resulting in 30 participants enrolled into the Q-GRFT arm and 15 participants enrolled into
the placebo arm. A clinician will apply two metered doses of Q-GRFT in each nostril (400μl
total) of the participant on the day of enrollment. Participants will be monitored in the
clinic for 1 hour after administration and return for a 24-hour post dose visit. If safe and
acceptable, a second period of daily administration by the participant for 13 days will
commence. Safety assessments will be performed at day 7, day 14, and day 28 visits after the
initiation of the second period. The expected duration of study participation for each
participant will be approximately 6-8 weeks. The primary endpoint is the proportion of
participants who experience a related Grade 2 or higher adverse event. Secondary and
exploratory endpoints include persistence and systemic absorption of Q-GRFT, acceptability
and the impact of Q-GRFT nasal spray on smell.