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A Study of BRII-297 in Healthy Adult Subjects

NCT05845840 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-01-18

No results posted yet for this study

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 \[(4 active: 2 placebo) - Cohorts 1 \& 2\] 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.

Conditions

Interventions

DRUG

BRII-297

Escalating doses of BRII-297 will be given in different cohorts i.e., Cohorts 1 through 6

DRUG

Placebo

Escalating doses of placebo will be given in different cohorts i.e., Cohorts 1 through 6

Sponsors & Collaborators

  • Brii Biosciences Limited

    lead INDUSTRY

Principal Investigators

  • Natasha Demi Martin · CMAX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-15
Primary Completion
2023-11-21
Completion
2024-01-17

Countries

  • Australia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05845840 on ClinicalTrials.gov