Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000075684
Ethics application status
Approved
Date submitted
1/12/2022
Date registered
23/01/2023
Date last updated
1/03/2024
Date data sharing statement initially provided
23/01/2023
Date results information initially provided
1/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-778 in Healthy Volunteers.
Scientific title
A Phase 1/2a, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-778 in Healthy Volunteers and in Subjects with Chronic Hepatitis B Infection, Including Subjects with Chronic Hepatitis D Infection - Part 1 conducted in Healthy Volunteers
Secondary ID [1] 308352 0
BJT-778-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B Virus (HBV) Infection 328143 0
Chronic Hepatitis D Virus (HDV) Infection 328144 0
Condition category
Condition code
Infection 325196 325196 0 0
Other infectious diseases
Oral and Gastrointestinal 325494 325494 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BJT-778 is being developed as a potent, selective neutralizing monoclonal antibody for the treatment of Chronic Hepatitis B Virus Infection (CHB) and Chronic Hepatitis D Virus Infection (CHD).
In the healthy volunteers, the sentinel 2 subjects in each dosing group will be randomized 1:1 and following 24 hours of no safety events, the subsequent subjects will be enrolled 5:1 (final 6:2). Dose escalation may proceed to the next level when all the subjects in the preceding dose group have completed dosing and Day 14 safety evaluations and
demonstrated an acceptable safety profile as determined by the Safety Review Committee
(SRC), which will include the Investigators currently enrolling subjects, contract research
organization (CRO) medical monitor and sponsor medical monitor (or designee). Subjects will be monitored with serial vitals, ECGs, safety laboratory assessments, and AEs recording.
Doses of BJT-778 in Cohort A include:
• A1) Dose 1 (75mg) x 1 subcutaneously (SC)
• A2) Dose 2 (300mg) x 1 SC
• A3) Dose 3 (900mg) x 1 SC
• A4) Optional Dose (900mg) x 1 SC
Intervention code [1] 324800 0
Treatment: Drugs
Comparator / control treatment
Placebo controlled trial.
Participants randomized to placebo will receive sterile 0.9% normal saline at the same volume as the BJT-778 dose in that dosing cohort as follows;
Doses of placebo in Cohort A include:
• A1) Dose 1 placebo x 1 subcutaneously (SC)
• A2) Dose 2 placebo x 1 SC
• A3) Dose 3 placebo x 1 SC
• A4) Optional Dose 3 placebo x 1 SC

Placebo will be drawn up into a syringe(s) for injection and labeled with the subject identification number by an unblinded pharmacist.
Control group
Placebo

Outcomes
Primary outcome [1] 333030 0
To evaluate the safety and tolerability of BJT-778. Subjects will be monitored with serial vitals, ECGs, safety labs, and adverse events recording from Screening to End of Treatment.
Timepoint [1] 333030 0
Participants will be assessed daily for adverse events from baseline to end of treatment visit. Adverse events are recorded using Division of AIDS Adverse Experience Reporting System (DAERS) from Screening to Day 85. Some of the known/possible adverse events are Immune-complex disease, changes in liver function/liver related blood tests and risk of allergic reactions.
Safety labs are collected regularly throughout the study from screening up to 12 weeks, these include Blood chemistries, Hematology, Coagulation and Urinalysis
Blood samples for Blood chemistries, Hematology are collected at screening and Days 1, 2, 8, 15, 29, 57 and Day 85 post-dose.
Urine samples are collected during Screening only.
Vital signs will be collected at every visit – heart rate measured using a pulse oximeter, blood pressure measured using a sphygmomanometer, temperature measured using a thermometer and respiratory rate counted by qualified personnel - all will be performed before blood draws. Supine ECGs will be performed in Screening. as well as pre-dose and 2hrs post-dose on Day 1.
Secondary outcome [1] 415578 0
To evaluate the plasma pharmacokinetics (PK) of BJT-778. PK parameters include but are not limited to Cmax, Clast, Tmax, Tlast, AUCinf, AUClast, t1/2, Lambda z, WF, and CL/F
Timepoint [1] 415578 0
PK blood samples are collected as follows:
• Cohorts A: Day 1 (pre-dose, 1, 4, and 8 hrs post-dose) and at every visit after dosing (Days 2, 4, 8, 15, 29, 57, and 85 post-dose)
Secondary outcome [2] 416688 0
To evaluate the immunogenicity of BJT-778 by measuring the proportion of subjects who develop anti-drug antibodies (ADAs)
Timepoint [2] 416688 0
Blood samples for ADA are collected as follows;
Day 1, 15, 29, 57 and Day 85 post-dose.

Eligibility
Key inclusion criteria
Cohort A (Healthy Volunteers)
• Able and willing to provide written informed consent (signed and dated) and any authorizations required by local law and can comply with all study requirements
• Male or female adults, age 18 to 55 years
• BMI 18 to 35 kg/m2
• Females: Non-pregnant and non-lactating; surgically sterile (e.g., tubal ligation, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), post-menopausal (defined as 12 months of spontaneous amenorrhea in females less than 55 years of age or, in females less than or equal to 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and FSH levels in the postmenopausal range for the laboratory involved) or, if engaged in sexual relations of child-bearing potential, subject is using an acceptable contraceptive method from the time of signing the informed consent form until at least 12 weeks after the last dose of Study Drug.
• Males: Surgically sterile or if engaged in sexual relations with a female of childbearing potential, subject is utilizing an acceptable contraceptive method during treatment with Study Drug and for at least 12 weeks after the last dose of Study Drug. Agree not to donate sperm for at least 12 weeks after the last dose of Study Drug.
• In good health, in the judgement of investigator
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cohort A (Healthy Volunteers)
• Serious or severe chronic conditions requiring frequent medical intervention or continuous pharmacologic management
• Medical or social conditions that would potentially interfere with the subject’s ability to comply with the study visits
• History of severe drug hypersensitivity or severe allergic reaction
• History of or current excess alcohol consumption within 1 year of screening, defined as weekly intake of greater than or equal to 14 drinks per week (average of greater than or equal to 2 drinks per day)
• Significant drug abuse/addiction within 1 year of Screening (excluding cannabis), or a
positive urine drug screen (except cannabis)
• Positive HBsAg, hepatitis C virus (HCV) antibody (Ab), or human immunodeficiency
virus (HIV) Ab
• 12-lead electrocardiogram (ECG) showing the following: having a corrected QTc interval greater than 450 msec for males and greater than 470 msec for females or less than 340 msec (Fridericia’s correction)
• Sustained supine systolic blood pressure (BP) of greater than 150 or less than90 mm Hg or supine diastolic BP of greater than 95 or less than50 mm Hg at Screening. The average of 2 assessments of BP will be used to exclude a subject
• Resting pulse rate at Screening of greater than 100 or less than 45.
• Donated or lost greater than 500 mL of blood within 60 days prior to enrollment into this study
• Active infection or febrile illness less than or equal to 14 days prior to Study Day 1
• Use of prescription or over-the-counter medications or herbal supplements less than or equal to 14 days prior to Study Day 1 or anticipated use during the 12 weeks post dosing
• Any clinically significant screening laboratory values outside of the normal limits
• Treatment with another investigational drug, biological agent, or device within 4 weeks of Screening or 5 half-lives of the investigational drug, whichever is longer

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)
Methods used to generate the sequence in which subjects will be randomised (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
Completed
Date of first participant enrolment
Anticipated
14/02/2023
Actual
17/02/2023
Date of last participant enrolment
Anticipated
15/05/2023
Actual
1/04/2023
Date of last data collection
Anticipated
15/08/2023
Actual
7/07/2023
Sample size
Target
32
Accrual to date
Final
23
Recruitment outside Australia
Country [1] 25106 0
New Zealand
State/province [1] 25106 0

Funding & Sponsors
Funding source category [1] 312593 0
Commercial sector/Industry
Name [1] 312593 0
Bluejay Therapeutics Inc
Country [1] 312593 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Bluejay Therapeutics Inc
Address
400 Concar Drive, Suite 3-101, San Mateo, CA 94402
Country
United States of America
Secondary sponsor category [1] 314207 0
None
Name [1] 314207 0
Address [1] 314207 0
Country [1] 314207 0
Other collaborator category [1] 282475 0
Commercial sector/Industry
Name [1] 282475 0
Novotech (Australia) Pty Limited
Address [1] 282475 0
Novotech (Australia) Pty Limited
Level 3, 235 Pyrmont Street Sydney, NSW, Australia - 2009
Country [1] 282475 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311920 0
Central Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 311920 0
Health and Disability Ethics Committees,
Minisitry of Health, 133 Molesworth Street
PO Box 5013, Wellington 6011
Ethics committee country [1] 311920 0
New Zealand
Date submitted for ethics approval [1] 311920 0
01/11/2022
Approval date [1] 311920 0
15/11/2022
Ethics approval number [1] 311920 0
2022 FULL 13730

Summary
Brief summary
Hepatitis B virus (HBV) infection is one of the most common infectious diseases in the world, with nearly 300 million people chronically infected worldwide. Chronic HBV infection can lead to serious complications such as cirrhosis, liver failure, hepatocellular carcinoma (HCC), and death. Approximately 820,000 people die every year due to consequences of Chronic HBV Infection (CHB).
Hepatitis delta virus (HDV) is the causative agent of the most severe form of viral hepatitis. Infection with HDV is dependent on the presence of HBV infection, as it uses HBV encoded envelope proteins (HBsAg) for infection and replication HDV infection can occur either simultaneously with HBV or, more commonly, as a superinfection in patients already chronically infected with HBV. Relative to CHB infection alone, CHD co-infection is associated with more severe liver disease, causing faster progression to cirrhosis, hepatocellular carcinoma, and liver failure.
Developing therapeutic strategies that deplete HBsAg levels, like monoclonal antibodies, may play a role in future regimens targeting functional cure. There is a clear need for additional treatment for CHD, particularly agents that improve response rates, are better tolerated, and simpler to administer than currently available treatments.
BlueJay Therapeutics has developed BJT-778, which has the potential to provide antiviral benefits by neutralizing and clearing HBV and HDV virions as well as by depleting HBsAg containing subviral particles, which may help to reconstitute HBV-specific immunity and contribute to functional cure for CHB. BJT-778 is a potent, selective neutralizing monoclonal antibody for the treatment of CHB and CHD.
This study will evaluate the safety, tolerability and pharmacokinetics of BJT-778 in Healthy volunteers.
Trial website
Trial related presentations / publications
Public notes
This study is being registered in four parts, which will involve the following participant cohorts:
- Part 1: conducted in healthy volunteers (Cohort A)
- Part 2: conducted in individuals with chronic hepatitis B infection, with participants sub-categorised into those with lower HbsAg levels (Cohort B) and higher HBsAg levels (Cohort C)
- Part 3: conducted in individuals with chronic hepatitis B and D co-infection (Cohorts D and F)
- Part 4: conducted in individuals with chronic hepatitis B (Cohort E)

Contacts
Principal investigator
Name 122838 0
Prof Ed Gane
Address 122838 0
New Zealand Clinical Research
3 Ferncroft St, Grafton Auckland 1010 New Zealand
Country 122838 0
New Zealand
Phone 122838 0
+64 021548371
Fax 122838 0
Email 122838 0
EdGane@adhb.govt.nz
Contact person for public queries
Name 122839 0
Ms Carole Ann Moore
Address 122839 0
Vice President, Clinical Operations, 400 Concar Drive, Suite 3-101, San Mateo, CA 94404
Country 122839 0
United States of America
Phone 122839 0
+001 650 796 5003
Fax 122839 0
Email 122839 0
cmoore@bluejaytx.com
Contact person for scientific queries
Name 122840 0
Dr Nancy Shulman, MD
Address 122840 0
Nancy Shulman, MD
Chief Medical Officer
951 Mariners Island Blvd., Suite 300
San Mateo, CA 94404
Country 122840 0
United States of America
Phone 122840 0
+0016506650669
Fax 122840 0
Email 122840 0
nshulman@bluejaytx.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.