Trials / Completed
CompletedNCT06057012
A Study of BRII-296 in Adults With Severe Postpartum Depression (PPD)
A Phase 2a, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Descriptive Efficacy of BRII-296 in Adults With Severe Postpartum Depression (PPD)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Brii Biosciences Limited · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to evaluate the safety and tolerability of BRII-296 administered by 2 intramuscular injections, administered with Depo Medrol as assessed by the incidence of adverse events, changes from baseline in vital signs, pulse oximetry, clinical laboratory evaluations, electrocardiograms (ECGs), Stanford Sleepiness Scale (SSS), Glasgow Coma Scale (GCS) in conjunction with clinical assessment, and suicidal ideation using the Columbia Suicide Severity Rating Scale (C-SSRS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BRII-296 | BRII-296 will be given via intramuscular injection. |
| DRUG | Depo Medrol | Depo Medrol will be given via intramuscular injection. |
Timeline
- Start date
- 2023-09-29
- Primary completion
- 2024-03-13
- Completion
- 2024-03-13
- First posted
- 2023-09-28
- Last updated
- 2025-01-27
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06057012. Inclusion in this directory is not an endorsement.