This is a Phase 1 open-label, Single Ascending Dose (SAD) escalation study to evaluate the safety, tolerability, and PK of BRII-296 when administered via IM injection to healthy adult subjects. Three dose-levels will be included with two planned brexanolone concentrations. A total of five planned and two optional cohort groups will be included in the study.
A Phase 1 Open-Label Single Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BRII-296 in Healthy Volunteers
Hormonal Birth Control OK
Drug & COVID Testing
GERD, Asthma, Cholesterol, Hypertension, HRT Meds Are OK
No Follow-Up Visit!
Cholecystectomy Is Not OK
Hip Injection Delivery Method
Name of Clinical Site
5355 Medpace Way, Cincinnati, OH, USA