RecruitingPhase 1ACTRN12624000405516

Phase 1 study of BRB-002 in healthy male volunteers

A Phase 1, randomized, double-blind, placebo-controlled single ascending dose study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous BRB-002 in healthy male volunteers

Sponsor

Bitterroot Australia Pty Ltd

Enrollment

48 participants

Start Date

Apr 23, 2024

Study Type

Interventional

Conditions

Cardiovascular

Summary

This is a first in human (FIH), double blind, placebo- controlled single ascending dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous BRB-002 in healthy male volunteers. Up to approximately 48 healthy male participants will be randomised into this study. Participants will be randomised to receive a dose of either BRB-002 or matching placebo. A total of 8 participants are planned for each cohort, with 6 participants receiving BRB-002 and 2 participants receiving placebo. For each cohort, a Safety Review Committee (SRC) will review all emerging safety and tolerability 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: MalesMin Age: 18 YearssMax Age: 50 Yearss

Plain Language Summary

Simplified for easier understanding

This is a first-in-human Phase 1 safety study of BRB-002, a new experimental medication developed by Bitterroot Australia. The study is designed to test whether increasing doses of BRB-002 — given as a subcutaneous (under the skin) injection — are safe and well-tolerated in healthy volunteers, and to understand how the body absorbs and processes it. Up to 48 healthy male volunteers will be enrolled across several dose groups. In each group, 6 participants will receive the active drug and 2 will receive a placebo (inactive injection). A safety committee reviews all results before each higher dose is tested. You may be eligible if you are a healthy male aged 18–50, have a BMI between 18 and 32 kg/m², and are not taking any prescription medications, supplements, or recreational drugs. You must also be a non-smoker and not have donated blood recently. This study is open to males only.

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. Up to 48 participants will b

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. Up to 48 participants will be enrolled in the study. Single ascending dose of BRB-002 or Matching placebo will be administered to study participants via subcutaneous (SC) injection in the proposed doses as mentioned below by the site staff. 6 participants will receive BRB-002 and 2 participants will receive placebo. A range of doses starting at 0.1 mg/kg up to 10 mg/kg or higher as determined by the safety results will be studied across up to 6 participant cohorts. After 2 weeks of observation and when determined safe, subsequent cohorts will be dosed. An adaptive study design will be used that allows for modification of study dose levels based on previous cohort safety data. In each cohort, 6 participants will receive BRB-002 and 2 participants will receive placebo. All participants will be monitored for at least 7 weeks. Adherence to the intervention will be monitored by the study staff, CRO and Sponsor.

Locations(1)

QLD, Australia

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