The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics
of BRII-297 in healthy adult subjects. The main aim of the study is to evaluate the safety
and tolerability after single dose intramuscular administration of BRII-297. The study also
aims at characterizing the PK profiles of BRII-297 and brexanolone after single dose
intramuscular administration.
Participants will be enrolled in 6 cohorts (3 planned and 3 optional) with 6 participants per
cohort [(4 active: 2 placebo) - Cohorts 1 & 2] and 10 participants per cohort [(8 active: 2
placebo) - Cohorts 3 to 6].
Randomization for each cohort will be a two-step process. Sentinel subjects for each cohort
will include 2 female subjects randomized 1:1 to BRII-297 or placebo who will be observed for
at least 24 hours to ensure no significant safety events before administering study drug to
the remaining non-sentinel subjects.
The estimated total duration for each subject is up to 43 days, including screening period
(28 days), dosing period (1 day), and post-dose follow-up period (14 days). IM injections
will be administered in the gluteal muscle.
Each participant in all cohorts will begin their inpatient stay at the clinical
investigational site on Day -1 and remain as an inpatient at the site for sample collection
and assessments for 15 days post dose (Day 15). Participants will be released at the end of
the inpatient period.