Phase 1 study of BRB-002 in healthy male volunteers

Phase 1

Recruiting

• Conditions: Cardiovascular; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12624000405516
• Lead Sponsor: Bitterroot Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-03
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed
2. Male participants aged 18 to 50 years of age (inclusive) at time of signing of informed consent
3. Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests and cardiac evaluation
4. 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 Criteria

1. 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
2. History of hypersensitivity to any of the IPs or excipients or to drugs of similar chemical classes.
3. An active history of clinically significant ECG abnormalities as determined by the Investigator.
4. 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.
5. Platelet count below the lower limit of normal.
6. Absolute neutrophil count below the lower limit of normal.
7. 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.
8. 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.
9. 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.
10. 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.
11. Any history of clinically significant medical or surgical illness requiring hospitalization in the prior 6 months
12. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified