RecruitingPhase 2ACTRN12625000273482

A study to assess the safety and tolerability of BRB-002 in adults with established atherosclerosis

A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous BRB-002 in Patients with Established Atherosclerosis

Sponsor

Bitterroot Bio Australia Pty Ltd

Enrollment

52 participants

Start Date

May 27, 2025

Study Type

Interventional

Conditions

Atherosclerosis

Summary

This is a double blind, placebo-controlled multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous BRB-002 in patients with established atherosclerosis, Up to approximately 52 participants with established atherosclerosis will be randomised into this study. The study will be conducted with a multiple dose phase (Part A) and a cohort expansion phase (Part B). Part A cohorts will contain up to 8 participants each with 6 participants receiving BRB-002 and 2 participants receiving placebo. Part B will be a dose expansion phase where a further 20 participants tested with the optimal dosing regimen determined during Part A. For each cohort, a Safety Review Committee (SRC) will review all emerging safety, tolerability, PK and PD data. The next planned cohort will be initiated only after it is confirmed by the SRC that the latest cohort dose was safe and tolerated.

Eligibility

Sex: Both males and femalesMin Age: 45 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

Atherosclerosis is a condition where fatty plaques build up inside the arteries, increasing the risk of heart attack and stroke. This Phase 2 study is testing a new injectable drug called BRB-002 to see if it is safe and well tolerated in people with this condition. Researchers also want to understand how the drug behaves in the body and whether it reduces inflammation in the artery walls, which is a key driver of the disease. Up to 52 participants will be enrolled. The study involves multiple injections given under the skin over several months, with imaging scans (including PET/CT) to measure inflammation in the arteries, along with regular blood tests and check-ups. Some participants will receive the active drug and others will receive a placebo, with neither the participants nor the researchers knowing who gets which. You may be eligible if you are aged 45 to 80, weigh between 50 and 120 kg, and have a history of heart attack, stroke, TIA, or carotid artery disease — or have two or more risk factors such as high blood pressure, high cholesterol, or diabetes. Women who could become pregnant and people with poorly controlled blood pressure, recent cardiac events, or severe kidney disease are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BRB-002 is a recombinant fusion protein that is designed to potently block CD47. Investigational Product BRB-002 or matching Placebo for subcutaneous (SC) injection. Approximately 52 participants wi

BRB-002 is a recombinant fusion protein that is designed to potently block CD47. Investigational Product BRB-002 or matching Placebo for subcutaneous (SC) injection. Approximately 52 participants will be enrolled in the study. Multiple doses of BRB-002 or matching placebo will be administered to study participants via subcutaneous (SC) injection by site staff. There will be up to four cohorts in Part A of the study with each cohort comprising of 6 participants receiving BRB-002 and 2 participants receiving placebo (total of approximately 8 participants per cohort). The first Part A cohort will evaluate weekly doses ranging from weekly 0.1 mg/kg to 5 mg/kg which were evaluated during the prior Phase 1 study. For subsequent cohorts, a Safety Review Committee (SRC) will review available data and decide on the the dosing regimen for the next cohort. An adaptive design will be used that allows for modification of study dose levels based on previous cohort safety, tolerability and PK data. Dose levels for each subsequent cohort will be determined by the SRC. Part B will be a dose expansion cohort with approximately a further 20 participants dosed at the optimal dose and frequency from Part A at a 1:1 randomisation to BRB-002 or placebo. All participants will be monitored for 13 weeks during the treatment phase and a further 5 weeks during a follow-up phase. Adherence to the intervention will be monitored by the study staff, CRO and Sponsor.