Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000405516
Ethics application status
Approved
Date submitted
1/03/2024
Date registered
3/04/2024
Date last updated
3/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase 1 study of BRB-002 in healthy male volunteers
Scientific title
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
Secondary ID [1] 311517 0
BRB-002-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular 332859 0
Condition category
Condition code
Cardiovascular 329576 329576 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327970 0
Treatment: Drugs
Comparator / control treatment
Matching placebo in single use vials. The placebo is a pH buffered salt solution with standard preservatives, but no active drug product.
Control group
Placebo

Outcomes
Primary outcome [1] 337364 0
To assess the safety and tolerability following single dose subcutaneous administration of BRB-002 in healthy participants.
Timepoint [1] 337364 0
Treatment Emergent Adverse Events assessed from start of IP administration on Day 1 through the end of study (Day 49)

Adverse Events (AEs) and Serious adverse events will be collected from start of signing the informed consent through the end of study (Day 49)
Primary outcome [2] 337801 0
To assess the safety and tolerability following single dose subcutaneous administration of BRB-002 in healthy participants.
Timepoint [2] 337801 0
Clinical lab parameters at Screening, Day -1, Day 2, Day 4, Day 7, Day 14, Day 21, Day 28 and end of study (Day 49) post dose
Primary outcome [3] 337802 0
To assess the safety and tolerability following single dose subcutaneous administration of BRB-002 in healthy participants.
Timepoint [3] 337802 0
Vital signs at Screening, Day -1, Day 1 predose and then at 1, 2, 6, 12, 24 hours, Days 4, 7, 14, 21, 28 and 49 post-dose (EOS)
Secondary outcome [1] 431588 0
To assess the Pharmacokinetics (PK) of single doses of subcutaneous BRB-002 in healthy participants
Timepoint [1] 431588 0
Blood sampling for PK parameters will be collected at Pre dose on Day 1, Post dose at 6hr, 12 hr, Day 1, Day 2, Day 4, Day 7, Day 14 and Day 28.
Secondary outcome [2] 433361 0
To assess the safety and tolerability following single dose subcutaneous administration of BRB-002 in healthy participants. (Primary Outcome)
Timepoint [2] 433361 0
ECG at Screening, Day -1, Day 2, Day 4, Day 21, and Day 49 (End of study)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be screened for study eligibility. Once eligibility has been determined, participants will be scheduled for clinic check-in/in-patient dates. On the day of dosing, participants will be given a randomisation number by study staff. This randomisation number will be assigned to either BRB-002 or placebo. At the clinic, only the pharmacy staff will know the assignment to receive BRB-002 or placebo. Syringes of BRB-002 and placebo will be labelled with the randomisation number only for dosing.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study biostatistician will provide a randomisation list for the study using a randomisation algorithm. This list will link the participant's randomisation number to assignment to BRB-002 or placebo.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/04/2024
Actual
Date of last participant enrolment
Anticipated
28/10/2024
Actual
Date of last data collection
Anticipated
16/12/2024
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 315808 0
Commercial sector/Industry
Name [1] 315808 0
Bitterroot Australia Pty Ltd
Country [1] 315808 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bitterroot Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 317934 0
Commercial sector/Industry
Name [1] 317934 0
Novotech (Australia) Pty Ltd.
Address [1] 317934 0
Country [1] 317934 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314664 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 314664 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 314664 0
Australia
Date submitted for ethics approval [1] 314664 0
07/02/2024
Approval date [1] 314664 0
14/03/2024
Ethics approval number [1] 314664 0
64/24 (HREC/105990-Alfred-2024)

Summary
Brief 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.



Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132334 0
Dr Gloria Wong
Address 132334 0
Q Pharm Pty Ltd, 300C Herston Road, Herston Queensland 4006
Country 132334 0
Australia
Phone 132334 0
+61 07 3707 2720
Fax 132334 0
Email 132334 0
g.wong@nucleusnetwork.com.au
Contact person for public queries
Name 132335 0
Gloria Wong
Address 132335 0
Q Pharm Pty Ltd, 300C Herston Road, Herston Queensland 4006
Country 132335 0
Australia
Phone 132335 0
+61 07 3707 2720
Fax 132335 0
Email 132335 0
g.wong@nucleusnetwork.com.au
Contact person for scientific queries
Name 132336 0
Gloria Wong
Address 132336 0
Q Pharm Pty Ltd, 300C Herston Road, Herston Queensland 4006
Country 132336 0
Australia
Phone 132336 0
+61 07 3707 2720
Fax 132336 0
Email 132336 0
g.wong@nucleusnetwork.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.