Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000198729
Ethics application status
Approved
Date submitted
19/01/2022
Date registered
4/02/2022
Date last updated
3/05/2023
Date data sharing statement initially provided
4/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to investigate the safety of multiple doses of BRN-002 administered intravenously (IV) in adult (18 to 65 years) healthy male and female participants
Scientific title
A Parallel Group, Phase 1 b, Double-blind, Placebo-controlled, Four-arm Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous BRN-002 Compared with Placebo in Male and Female Healthy Adult Participants
Secondary ID [1] 306040 0
BRN-002-HV-102
Universal Trial Number (UTN)
U1111-1271-1023
Trial acronym
None
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerosis 324681 0
Condition category
Condition code
Cardiovascular 322126 322126 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study consists of three active treatment arms and one placebo arm.
Participants will receive BRN-002 or Placebo once every 14 days over 7 weeks for a total of 4 doses intravenously.
Arm 1- BRN-002 500 mg/kg IV
Arm 2- BRN-002 1000 mg/kg IV
Arm 3- BRN-002 1500 mg/kg IV
Arm 4- Placebo 0 mg/kg IV
Study drugs will be administered under the supervision of study personnel and treatment compliance will be verified according to the site's SOP (Standard Operating Procedures). The date and time of each dose administered in the clinic will be recorded in the source documents.
Intervention code [1] 322441 0
Treatment: Drugs
Comparator / control treatment
Placebo - 0.9% NaCl (Sodium Chloride) Infusion Bags
Control group
Placebo

Outcomes
Primary outcome [1] 329894 0
To assess the safety and tolerability of BRN-002 following multiple IV doses relative to placebo in healthy volunteers. It will be measured by the number of treatment-emergent adverse events during this study either reported by the investigator or participants.

Potential adverse events, which may include hearing abnormalities, have been observed with similar drugs at higher doses than what is planned for this study. Hearing abnormalities have not been observed to date with BRN-002. Participants will be monitored using audiometry testing throughout the study.
Timepoint [1] 329894 0
Through out the study duration.
Secondary outcome [1] 404189 0
To investigate the PK of BRN-002 following multiple IV doses in healthy volunteers.
This will be measured by BRN-002 plasma concentrations.
Timepoint [1] 404189 0
On dosing days, blood will be collected at 30 minutes prior to dosing, 1 hour after start of infusion and 2 hr after start of infusion, which is also the end of infusion. After the end of infusion, the time points will be 15 minutes, 30 minutes, 1 hour, 1.5, 2, 3, 4, 5, 6, 8, 24 and 48 hours.
Secondary outcome [2] 404190 0
To evaluate the saftey of BRN-002 relative to placebo by
clinical laboratory test results like hematology and serum chemistry
ECGs (12 lead ECGs parameters will be measured) and
audiologic evaluations (includes audiogram and tympanogram) following multiple IV doses in healthy volunteers.
Timepoint [2] 404190 0
On dosing days (Day 1, 15, 29, and 43 )
Vital signs will be measured at - pre-dose, mid infusion, end of infusion, 1 hour, 2, 24 and 48 hours.
Clinical laboratory - pre-dose, and then 24 hours and 48 hours after end of infusion.
ECG- On Day 1 and 43, at 60 minutes pre-dose, mid infusion, end of infusion, then 15 minutes, 1 hour, 2, 4, and 24 hours.
ECG- on Day 15 and 29, at 60 minutes pre-dose and at the end of infusion.
Audiometry testing- at Screening, and prior to discharge from clinic at the end of each dosing period.

Eligibility
Key inclusion criteria
1. Male or female participant between 18 to 65 years of age (both inclusive)
2. Body Mass Index (BMI) within the range 18.5 to 35 kg/m2 (inclusive) at screening
3. Healthy participants who have clinical laboratory parameters within normal range
4. Participants with normal audiogram at screening
5. Normal ECG at screening
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Prior history of hearing abnormalities, inner ear disorders, frequent ear infections or vestibular disturbance
2. Non-insulin or insulin-dependent diabetes mellitus (documented or on HbA1c analysis with HbA1c more than 6.5%)
3. Documented inflammatory disease
4. Infectious disease
5. Lymphoma, leukemia or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of active disease and low or no risk of recurrence
6. Cognitive, psychological, or addictive conditions that in opinion of the investigator may interfere with participant compliance
7. Acute illness, hospital admission or major surgery within 30 days prior to dosing
8. Use of any prescription medication within 14 days or 5 half-lives prior to dosing
9. Use of or intended use of prohibited over the counter medications or natural health products within 7 days prior to dosing or intended use during study
10. Received any vaccination within 14 days prior to dosing
11. Current enrollment or past participation in another investigational study within 30 days of screening
12.Low-density lipoprotein cholesterol more than 190 mg/dL
13.QtcF more than 450 msec for male or more than 470 msec for female participants a PR interval outside the range 120 to 220 msec.
14. Positive human immunodeficiency virus (HIV) antibody test or positive hepatitis B surface antigen or hepatitis C antibody test at screening
15. Positive COVID-19 test at screening

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)
A sealed envelope that contains the study intervention assignment for each participant will be provided to the investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
No formal hypothesis testing is planned for this trial and no power or sample size calculations were performed. The sample size is based on the pragmatic considerations of this trial.
The primary safety endpoint, the number of treatment-emergent adverse events (TEAEs), will be analyzed using the Safety Analysis Set. The number and percentage of participants with TEAEs will be summarized by system organ class, preferred term, and treatment and by maximum severity and relationship to study treatment.
Listings of TEAEs by treatment arm and by participant will also be provided.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2022
Actual
20/02/2022
Date of last participant enrolment
Anticipated
12/04/2022
Actual
22/06/2022
Date of last data collection
Anticipated
22/06/2022
Actual
22/06/2022
Sample size
Target
32
Accrual to date
Final
34
Recruitment outside Australia
Country [1] 24401 0
New Zealand
State/province [1] 24401 0
Auckland

Funding & Sponsors
Funding source category [1] 310376 0
Commercial sector/Industry
Name [1] 310376 0
Beren Therapeutics, PBC
Country [1] 310376 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Beren Therapeutics, PBC
Address
9200, Sunset Blvd, Ste 1010
West Hollywood, CA, 90069
Country
United States of America
Secondary sponsor category [1] 311526 0
None
Name [1] 311526 0
Address [1] 311526 0
Country [1] 311526 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310029 0
Central health and Disability Ethics Committee
Ethics committee address [1] 310029 0
Ethics committee country [1] 310029 0
New Zealand
Date submitted for ethics approval [1] 310029 0
10/11/2021
Approval date [1] 310029 0
03/12/2021
Ethics approval number [1] 310029 0

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

Contacts
Principal investigator
Name 116242 0
Dr Paul Hamilton
Address 116242 0
New Zealand Clinical Research
3 Ferncroft street, Grafton 1010 Auckland,
Country 116242 0
New Zealand
Phone 116242 0
+64 211341110
Fax 116242 0
Email 116242 0
Paul.Hamilton@NZCR.co.nz
Contact person for public queries
Name 116243 0
Scott Riccio
Address 116243 0
Trial Manager
Beren Therapeutics
9200 Sunset Blvd, Ste 1010,
West Hollywood, CA 90069
Country 116243 0
United States of America
Phone 116243 0
+1 323 538 6434
Fax 116243 0
Email 116243 0
clinicaltrials@berentx.com
Contact person for scientific queries
Name 116244 0
Scott Riccio
Address 116244 0
Trial Manager
Beren Therapeutics
9200 Sunset Blvd, Ste 1010,
West Hollywood, CA 90069
Country 116244 0
United States of America
Phone 116244 0
+1 323 538 6434
Fax 116244 0
Email 116244 0
clinicaltrials@berentx.com

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.