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First received: April 12, 2023

Clinical Trial: A Study of BRII-297 in Healthy Adult Subjects

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Postpartum Depression

Study Type: INTERVENTIONAL


Official Title: A Phase 1 Randomized, Double-blind, Placebo-controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BRII-297 in Healthy Adult Subjects

Brief Summary: 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) -…

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