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

Inclusion Criteria4

Written informed consent must be obtained before any assessment is performed
Male participants aged 18 to 50 years of age (inclusive) at time of signing of informed consent
Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests and cardiac evaluation
Body mass index (BMI) between 18.0 kg/m2 and 32.0 kg/m2, inclusive, with minimum and maximum body weights of 50.0 and 120.0 kg, inclusive

Exclusion Criteria12

Participation in another clinical study of another investigational product within 5 half-lives of enrollment, or within 30 days for small molecules or until the expected pharmacodynamic effect has returned to baseline for biologics, whichever is longer; or longer if required by local regulations
History of hypersensitivity to any of the IPs or excipients or to drugs of similar chemical classes.
An active history of clinically significant ECG abnormalities as determined by the Investigator.
Hemoglobin level below the lower limit of normal. Known or suspected thalassemia trait carriers or a mean corpuscular volume (MCV) outside the range of normal.
Platelet count below the lower limit of normal.
Absolute neutrophil count below the lower limit of normal.
Donation or loss of 400 ml or more of blood within eight (8) weeks prior to IP administration, or longer if required by local regulation.
Use of nicotine-containing products (e.g., chews tobacco, smokes cigarettes, uses nicotine patch or cigarette-like smoking/vaping implements such as electronic cigarettes, cigarillos, and cigars) within 4 weeks prior to IP administration and for the duration of the study.
Use of any prescription drugs, including prescribed medicinal use of cannabis/marijuana, and vaccinations within four weeks prior to IP administration, and use of over the counter (OTC) medication, dietary supplements (vitamins included) within one week prior to IP administration.
Positive urine drug screen (UDS) including recreational cannabis use, urine cotinine, or breath alcohol test at the Screening Visit or upon admission to the Treatment Phase or unwilling to refrain from illicit drugs or nicotine during the study.
Any history of clinically significant medical or surgical illness requiring hospitalization in the prior 6 months
History of drug or alcohol abuse within the 12 months prior to IP administration, or evidence of such abuse as indicated by the laboratory assays conducted during screening or baseline.

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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.