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Clinical trial

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)

ID
Name
BRII-296-002
Description
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).
Trial arms
Trial start
2023-09-29
Estimated PCD
2024-03-13
Trial end
2024-03-13
Status
Completed
Phase
Early phase I
Treatment
BRII-296
2 intramuscular injections 300 mg each of BRII-296 admixed with Depo Medrol 40 mg/mL per injection, will be administered in participants with PPD.
Arms:
BRII-296 600 mg
Size
11
Primary endpoint
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
From the first dose of study drug up to Day 45
Number of Participants With Adverse Events (AEs) According to Severity
From the first dose of study drug up to Day 45
Number of Participants With Change From Baseline in Clinically Significant Vital Sign Parameters
Baseline up to Day 45
Number of Participants With Abnormal Electrocardiogram (ECG) Parameters
From the first dose of study drug up to Day 45
Number of Participants With Change From Baseline in Clinically Significant Clinical Laboratory Evaluations
From the first dose of study drug up to Day 45
Number of Participants With Columbia-Suicide Severity Rating Scale (C-SSRS) Responses
Baseline up to Day 45
Change From Baseline in Glasgow Coma Scale (GCS) Score
Baseline up to Day 45
Change From Baseline in Stanford Sleepiness Scale (SSS) Score
Baseline up to Day 45
PK of Brexanolone: Maximum Observed Plasma Concentration (Cmax)
Day 1- Day 45
PK of Brexanolone: Time to Reach Cmax (Tmax)
Day 1- Day 45
PK of Brexanolone: Area Under the Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last)
Day 1- Day 45
PK of Brexanolone: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC0-inf)
Day 1- Day 45
PK of Brexanolone: Apparent Terminal Elimination Half-life (t½)
Day 1- Day 45
PK of Brexanolone: Apparent Clearance (CL/F)
Day 1- Day 45
PK of Brexanolone: Volume of Distribution (Vz/F)
Day 1- Day 45
Eligibility criteria
Inclusion Criteria: * Participant either must have ceased lactating at screening or is still lactating actively breastfeeding at screening , must agree temporarily cease giving breast milk to her infant(s) * Participant has had a Major Depressive Episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM-5) * Participant was \<12 months postpartum * Participant is amenable to intramuscular administration of investigational product on Day 1 and remaining inpatient until at least Day 4 Exclusion Criteria: * Active psychosis * Attempted suicide associated with current episode of postpartum depression * Medical history of seizures * Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 11, 'type': 'ACTUAL'}}
Updated at
2024-03-22

1 organization

1 product

1 indication

Organization
Brii Biosciences
Product
BRII-296
Indication
Postpartum Depression