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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001219370p
Ethics application status
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Submitted, not yet approved
Date submitted
Help: Date submitted
2/09/2026
Date registered
Help: Date registered
2/10/2026
Date last updated
Help: Date last updated
2/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
2/10/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
A study of BRD-333 in Healthy Adult Participants
Scientific title
A Randomized, Double Blind, Placebo Controlled Phase 1 First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Subcutaneous Doses of BRD-333 in Healthy Adults
Additional trial identifiers [1] 318310 0
BRD-333-001
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Inflammatory diseases 343439 0
Autoimmune diseases 343636 0
Condition category
Condition code
Inflammatory and Immune System 339531 339531 0 0
Other inflammatory or immune system disorders
Inflammatory and Immune System 339750 339750 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Part A Single Ascending Dose (SAD)
Part A will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous injection of BRD-333 in healthy adults. A registered nurse will administer the study intervention (BRD-333 or placebo) in the clinical research unit. The planned dose levels are 300mg (cohort 1), 600mg (cohort 2) and 1200mg (cohort 3). Each Part A cohort will dose 2 sentinel participants (1 placebo, 1 BRD-333) on Day 1 and the remaining 6 participants will be administered BRD-333 or placebo at least 3 days after the last sentinel dosed.

Part B Multiple Ascending Doses (MAD)
Part B is escalating multiple doses of BRD-333 or placebo administered on 4 separate days over one month (Day 1, 8, 15 and 22) as a subcutaneous injection. A registered nurse will administer the study intervention (BRD-333 or placebo) in the clinical research unit. This part is designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of BRD-333 following weekly dose exposures over 4 weeks. Two cohorts are planned to evaluate 2 escalating doses of BRD-333. The planned dose levels are 150 mg and 300 mg.,
Intervention code [1] 335205 0
Treatment: Drugs
Description of the comparator or control
The placebo used in both Part A and B is a sterile saline solution commercially available.
Control group
Placebo

Outcomes
Primary outcome [1] 346708 0
Part A: Incidence of treatment-emergent Adverse Events (AEs) following a single dose of BRD-333.
Timepoint [1] 346708 0
All adverse events will be recorded from time of signing consent to the end of study visit (day 169).
Primary outcome [2] 346709 0
Part B: Incidence of treatment-emergent AEs following multiple doses of BRD-333.
Timepoint [2] 346709 0
All adverse events will be recorded from time of signing consent to the end of study visit (day 169).
Primary outcome [3] 346735 0
Occurrence of clinically significant changes from baseline in laboratory values (hematology) following a single dose of BRD-333.
Timepoint [3] 346735 0
Clinical lab safety tests will be collected at Baseline, day 2, 4, 8, 29, 57, 85 and at the end of study visit (day 169).
Secondary outcome [1] 467143 0
Characterize the pharmacokinetics (PK) profile of BRD-333 following a single dose using serial serum samples collected at predefined timepoints.
Timepoint [1] 467143 0
Blood samples will be collected for PK analysis at the following time points: once daily on days 1-4 (pre-dose, 24, 48 and 72 hrs post dose), 6, 8, 15, 22, 29, 43, 57, 85, 113, 141 and Day 169 (end of study).
Secondary outcome [2] 467206 0
Characterize the pharmacokinetics profile of BRD-333 following multiple doses using serial serum samples collected at predefined timepoints.
Timepoint [2] 467206 0
Blood samples will be collected for PK analysis at the following time points: once daily on days 1-4 (pre-dose, 24, 48 and 72 hrs post dose), 8, 11, 13, 15, 18, 20, 22, 25, 29, 57, 85, 113, 141 and Day 169 (end of study).
Secondary outcome [3] 467208 0
Characterize the pharmacodynamics (PD) profile of BRD-333 following a single dose.
Timepoint [3] 467208 0
Blood samples will be obtained to assess PD profile of BRD-333 will be collected on days -1, 1, 4, 8, 15, 29, 43, 57, 85, 113 and 169 (end of study).
Secondary outcome [4] 467209 0
Characterize the pharmacodynamics profile of BRD-333 following multiple doses.
Timepoint [4] 467209 0
Blood samples will be obtained to assess PD profile of BRD-333 will be collected on days -1, 1, 4, 8, 15, 22, 29, 57, 85, 113 and 169 (end of study).
Secondary outcome [5] 468141 0
Part A Primary Outcome: Severity of treatment-emergent AEs following a single dose of BRD-333.
Timepoint [5] 468141 0
All adverse events will be recorded from time of signing consent to the end of study visit (day 169).
Secondary outcome [6] 468142 0
Part A Primary Outcome: Relatedness of treatment-emergent AEs following a single dose of BRD-333.
Timepoint [6] 468142 0
All adverse events will be recorded from time of signing consent to the end of study visit (day 169).
Secondary outcome [7] 468145 0
Part B Primary Outcome: Severity of treatment-emergent AEs following multiple doses of BRD-333.
Timepoint [7] 468145 0
All adverse events will be recorded from time of signing consent to the end of study visit (day 169).
Secondary outcome [8] 468146 0
Part B Primary Outcome: Relatedness of treatment-emergent AEs following multiple doses of BRD-333.
Timepoint [8] 468146 0
All adverse events will be recorded from time of signing consent to the end of study visit (day 169).
Secondary outcome [9] 468147 0
Primary Outcome: Occurrence of clinically significant changes from baseline in vital signs following a single dose of BRD-333.
Timepoint [9] 468147 0
Vital signs will be collected at baseline and on days 1-4, 6, 8, 15, 22, 29, 43, 57, 85, 113, 141 and at the end of study visit (Day 169).
Secondary outcome [10] 468148 0
Primary Outcome: Occurrence of clinically significant changes from baseline in 12-lead ECG readings following a single dose of BRD-333.
Timepoint [10] 468148 0
ECGs will be completed at baseline and on days 1, 4, 6, 8, 29, 85 and the end of study visit (Day 169).
Secondary outcome [11] 468149 0
Characterize the pharmacodynamics (PD) profile of BRD-333 following a single dose.
Timepoint [11] 468149 0
Blood samples will be obtained to assess PD profile of BRD-333 will be collected on days -1, 1, 4, 8, 15, 29, 43, 57, 85, 113 and 169 (end of study).
Secondary outcome [12] 468767 0
Primary Outcome: Occurrence of clinically significant changes from baseline in laboratory values (chemistry) following a single dose of BRD-333.
Timepoint [12] 468767 0
Clinical lab safety tests will be collected at Baseline, day 2, 4, 8, 29, 57, 85 and at the end of study visit (day 169).
Secondary outcome [13] 468768 0
Primary Outcome: Occurrence of clinically significant changes from baseline in laboratory values (urinalysis) following a single dose of BRD-333.
Timepoint [13] 468768 0
Urinalysis will be conducted at Baseline, day 4, 8, 29, 57, 85 and at the end of study visit (day 169).
Secondary outcome [14] 468769 0
Characterize the pharmacodynamics profile of BRD-333 following multiple doses.
Timepoint [14] 468769 0
Blood samples will be obtained to assess PD profile of BRD-333 will be collected on days -1, 1, 4, 8, 15, 22, 29, 57, 85, 113 and 169 (end of study).

Eligibility
Key inclusion criteria
Have a body mass index (BMI) between 18.0 and 32.0 kg/m2 and weight between 50 and 100 kg.

Must be in good general health, with no significant medical history, and no clinically significant abnormalities on physical examination at start of study.

A woman of childbearing potential (WOCBP) or fertile man must have been using an acceptable method of contraception for greater than or equal to 30 days prior to Screening and agrees to continue using the acceptable method of contraception until 10 months after the last dose of BRD-333.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Female participant who is pregnant, planning to become pregnant, or currently breastfeeding, or lactating in the last 90 days prior to Day –1.
Men with female partners who are planning to become pregnant by the participant while the participant is on study.
History of any significant autoimmune, cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, infectious, inflammatory, musculoskeletal, neurological, psychiatric, renal, or respiratory diseases, that, in the opinion of the Principal Investigator (PI) or Sponsor, would jeopardize the safety of the participant, prevent compliance with the protocol, prevent complete participation in the study, or compromise interpretation of study data.
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory tests beyond what is consistent with a healthy population in the region.
Smokes greater than 5 cigarettes or equivalent (eg, cigars, vaping, nicotine patches) per week.
Positive drug and/or alcohol screen at Screening.
Unwilling to abstain from alcohol from 48 hours prior to admission to the site, while housed at the site, or from 48 hours prior to any follow up visits.
Unwilling to abstain from the use of marijuana or other potential drugs of abuse during the study.
History of any drug or alcohol abuse in the past he past 2 years defined as >21 standard drinks of alcohol per week for males and >14 standard drinks of alcohol per week for females. Where 1 standard drink = 375 mL of mid-strength beer (3.5% alcohol/volume), 100 mL of wine (13.5% alcohol/volume), or 30 mL of spirits (40% alcohol/volume).
History of substance abuse (drugs or alcohol) or dependency or history of recreational nasal or intravenous drug use over the last 2 years.
Unwilling to abstain from weightlifting or strenuous exercise while housed at the site and in the 48 hours prior to any study visit after the Screening visit.

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)
Sealed Opaque Envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/11/2026
Actual
Date of last participant enrolment
Anticipated
22/10/2027
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 30106 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 46501 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 322870 0
Commercial sector/Industry
Name [1] 322870 0
Birdseye Therapeutics Inc
Country [1] 322870 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Birdseye Therapeutics Inc
Address
Country
United States of America
Secondary sponsor category [1] 325798 0
Commercial sector/Industry
Name [1] 325798 0
InClin Pty Ltd
Address [1] 325798 0
Country [1] 325798 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 321305 0
Bellberry Human Research Ethics Committee K
Ethics committee address [1] 321305 0
Ethics committee country [1] 321305 0
Australia
Date submitted for ethics approval [1] 321305 0
15/09/2026
Approval date [1] 321305 0
Ethics approval number [1] 321305 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 153298 0
Dr Robert Holden
Address 153298 0
Linear Clinical Research, Block B, Hospital Avenue, Nedlands WA 6009
Country 153298 0
Australia
Phone 153298 0
+61 8 6382 5100
Fax 153298 0
Email 153298 0
[email protected]
Contact person for public queries
Name 153299 0
Mr Taylor Kilfoil
Address 153299 0
InClin Pty Ltd, Suite 210, 25/29 Berry Street, North Sydney, NSW, Australia, 2060.
Country 153299 0
Australia
Phone 153299 0
+61408880403
Fax 153299 0
Email 153299 0
[email protected]
Contact person for scientific queries
Name 153300 0
Mr Taylor Kilfoil
Address 153300 0
InClin Pty Ltd, Suite 210, 25/29 Berry Street, North Sydney, NSW, Australia, 2060.
Country 153300 0
Australia
Phone 153300 0
+61408880403
Fax 153300 0
Email 153300 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.