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Trial registered on ANZCTR


Registration number
ACTRN12625000281493p
Ethics application status
Not yet submitted
Date submitted
28/03/2025
Date registered
11/04/2025
Date last updated
11/04/2025
Date data sharing statement initially provided
11/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of BJT-678 in subjects with chronic Hepatitis B Infection, including subjects with Chronic Hepatitis D infection
Scientific title
A Phase 1a/b, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-628 in Healthy Volunteers and in Subjects with Chronic Hepatitis B Infection, Including Subjects with Chronic Hepatitis D Infection- Part 1b.
Secondary ID [1] 313849 0
BJT-628-001
Universal Trial Number (UTN)
Trial acronym
Linked study record
This record is linked to ACTRN12624001003561 which describes 1a of the study while this record describes 1b of the study.

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B Infection 336503 0
Chronic Hepatitis D Infection 336504 0
Condition category
Condition code
Infection 333012 333012 0 0
Other infectious diseases
Oral and Gastrointestinal 333455 333455 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
Investigational Product (IP): BJT-628
Dosage Form: Capsules for oral administration
Method of administration: Orally

The study consists of two parts (Part 1a and Part 1b). This registration is for Part 1b. The Phase 1b portion of this study is a multi-center, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and antiviral activity of 28 days of BJT-628 oral capsules or placebo oral capsules in subjects with chronic HBV infection (Part C) who are virally suppressed on nucleos(t)ide therapy and a cohort of subjects with chronic hepatitis D virus (HDV) infection (Part D).

Part C MAD in Chronic Hepatitis B (CHB) Infected Subjects: Up to 40 chronic HBV infected subjects will be enrolled across 4 cohorts.
Part C may initiate when 2 cohorts in Part B have been found to be safe and well tolerated based on safety follow-up of 7 days post-last dose. Subjects will receive either administered oral BJT-628 oral capsules or placebo oral capsules once daily or every 12 hours for 28 days. The specific dose and frequency (once daily or every 12 hours) are determined by review of the data and endorsement by the Safety Review Committee dedicated to the clinical study.
-Cohort 1: BJT-628 (less than or equal to highest tolerated dose in Part B) or placebo
-Cohort 2: BJT-628 (less than or equal to 3 x Cohort 1 dose) or placebo
-Cohort 3: BJT-628 (less than or equal to 3 x Cohort 2 dose) or placebo
-Cohort 4: BJT-628 (less than or equal to 3 x Cohort 3 dose) or placebo
Subjects will be followed for 28 days after the last dose of study drug.

Part D Chronic Hepatitis D (CHD) Infected Subjects: Up to 10 chronic CHD virus infected subjects
An optional Part D may initiate when 1 cohort in Part C has demonstrated antiviral activity and was found to be safe and well tolerated based on safety follow-up of 7 days post-last dose. The dose evaluated in the below cohort will not exceed the highest tolerated dose evaluated in Part B.
Eight subjects will be randomized 3:1 (active to placebo) and administered oral BJT-628 oral capsules or placebo oral capsules once daily or every 12 hours for 28 days. The specific dose and frequency (once daily or every 12 hours) are determined by review of the data and endorsement by the Safety Review Committee dedicated to the clinical study.

-Cohort 1 (n=8): BJT-628 (less than or equal to highest tolerated dose in Part B) or placebo.

Subjects will be followed for 28 days after the last dose of study drug. Adherence to intervention is monitored by the site staff.
Intervention code [1] 330432 0
Treatment: Drugs
Comparator / control treatment
Placebo capsules contain glycerol monocaprylo caprate (Crodamol GMCC), lauroyl polyoxylglycerides, NF, EP (Gelucire 44/14) and glyceryl monooleate, NF, EP (Peceol), ascorbyl palmitate, NF, butylated hydroxyanisole, NF, EP (BHA) but no active substance, and are identical in size and appearance to the corresponding active capsules.
Matching placebo will be administered with water.
Control group
Placebo

Outcomes
Primary outcome [1] 340553 0
To evaluate the safety and tolerability of BJT-628 by evaluating the following- -Incidence and severity of treatment-emergent adverse events (TEAEs) will be assessed for severity and causality (relationship of event to the investigational product) by the study investigator using the specified definitions. - Changes in clinical laboratory parameters including blood chemistry, Hematology, coagulation and urinalysis. This will be a composite primary outcome which will take into account AE and Laboratory parameters.
Timepoint [1] 340553 0
-Adverse events monitored daily from screening to end of study (EOS) Day 57 for Part C and D post first dose administration. - Safety Lab parameters will be monitored on screening, Day 1, Day 8, Day 28 and Day 57 post first dose administration.
Secondary outcome [1] 444440 0
To evaluate the anti-hepatitis B virus (HBV) activity of BJT-628 in CHB subject
Timepoint [1] 444440 0
Assessed on Day 1, Day 8, day 15, Day 22, Day 28, Day 36, Day 43 and Day 57 post first dose administration.
Secondary outcome [2] 444441 0
To evaluate the anti-hepatitis D virus (HDV) activity of BJT-628 in CHD subjects
Timepoint [2] 444441 0
Assessed on Day 1, Day 8, day 15, Day 22, Day 28, Day 36, Day 43 and Day 57 post first dose administration.

Eligibility
Key inclusion criteria
1. 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
2. Male and female adults.
3. 18 to 65 years of age, inclusive
4. Chronic HBV infection more than equal to 6 months (e.g., positive for serum Hepatitis B surface antigen (HBsAg) more than equal to 6 months)
5. HBsAg > Lower limit of quantification (LLOQ) at Screening
6. HBV DNA LLOQ at Screening
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant or lactating females
2. Male or female subjects of childbearing potential unwilling to comply with contraception requirements during the study.
3. History or presence of central neurological or peripheral neuropathy disease from physical examination
4. Family history of peripheral neuropathy
5. History of or current migraine headaches
6. Diabetes
7. Treatment with a different investigational drug other than BJT-628, a biological agent or device within 4 weeks or 5 half-lives of Day 1, whichever is longer
8. Clinically significant medical history of:
a) Cardiac diseases (e.g., myocardial infarctions, stroke, arrhythmia, heart failure, and coronary heart disease),
b) Autoimmune diseases (e.g., lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis, thyroiditis), or
c) Malignancies within 3 years. Malignancy that has been successfully surgically resection and considered cured would not exclude the subject
d) Severe psychiatric disease, especially depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease
e) Liver diseases (not including the disease(s) under evaluation), such as nonalcoholic steatohepatitis (NASH), alcohol-associated hepatitis, cholestatic liver disease, other viral (e.g., HAV or HCV) or non-viral hepatitis that has the potential to impact interpretation of data. Exceptions to this criterion for CHB and CHD subjects include fatty liver without any signs of steatohepatitis or past HCV infection that was successfully treated greater than or equal to 6 months prior to Screening
9. History of hypersensitivity to any of the components in the BJT-628 formulation
10. History of excess alcohol consumption within one year of Screening, defined as weekly intake of greater than or equal to 14 drinks per week (average of more than or equal to 2 drinks per day)
11. History of drug abuse/addiction within one year of Screening (except cannabis)
12. 12-lead electrocardiogram (ECG) with a corrected QTc interval >450 msec for males and >470 msec for females or 500 mL of blood within 60 days prior to Study Day 1
14. Unwillingness to comply with study procedures, including follow up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator
15. Have any conditions (medical, social, psychiatric, or other), which in the opinion of the Investigator would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the study
Phase 1B (CHB and CHD subjects)
16. Fibroscan >8.5 kPa within 1 year of Screening
17. History of and/or current decompensated liver disease as evidenced by ascites, hepatic encephalopathy, and/or gastric or esophageal varices
18. Received solid organ or bone marrow transplant
19. Currently taking, or took within one month of Screening, any immunosuppressing drugs (e.g., prednisone). If the subject received a short course, the situation may be discussed with the medical monitor, or designee.
20. Diagnosed hepatocellular carcinoma (HCC) or suspected HCC as evidenced by screening alpha-fetoprotein more than equal to 20 ng/mL
21. Screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values that would render a subject unsuitable for inclusion:
a) ALT or aspartate aminotransferase (AST) >2× upper limit of normal (ULN)
b) Total bilirubin >1.2× ULN, except for subjects with Gilbert’s (normal direct bilirubin)
c) Serum albumin 1.2
e) Platelet count <140 k/mm3
f) Hemoglobin <12.0 g/dL for males and <11.0 g/dL for females
g) Absolute neutrophil count <1000/mm3
h) Estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m2 by Cockcroft-Gault
i) Positive test for human immunodeficiency virus antibody (anti-HIV1/anti-HIV2)
j) Positive test for HCV RNA
k) Positive test for HDV RNA, except for CHD cohort(s)
22. Clinically significant acute or chronic illnesses in medical history (e.g., previous acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening, chronic kidney disease, immune deficiencies, uncontrolled infection, seizure disorder, or hemolytic anemia)
23. History of bleeding diathesis or coagulopathy

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)
central randomisation by phone/fax/computer
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
Who is / are masked / blinded?



Intervention assignment
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
30/05/2025
Actual
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 26850 0
New Zealand
State/province [1] 26850 0
Hamilton
Country [2] 26851 0
Moldova, Republic Of
State/province [2] 26851 0
Country [3] 26852 0
Ukraine
State/province [3] 26852 0

Funding & Sponsors
Funding source category [1] 318315 0
Commercial sector/Industry
Name [1] 318315 0
Bluejay Therapeutics, Inc
Country [1] 318315 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Bluejay Therapeutics, Inc
Address
Country
United States of America
Secondary sponsor category [1] 320706 0
None
Name [1] 320706 0
Address [1] 320706 0
Country [1] 320706 0
Other collaborator category [1] 283399 0
Commercial sector/Industry
Name [1] 283399 0
Novotech(Australia) Pty Limited
Address [1] 283399 0
Country [1] 283399 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316950 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 316950 0
Ethics committee country [1] 316950 0
New Zealand
Date submitted for ethics approval [1] 316950 0
17/04/2025
Approval date [1] 316950 0
Ethics approval number [1] 316950 0

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

Contacts
Principal investigator
Name 139534 0
Prof Edward Gane
Address 139534 0
New Zealand Clinical Research, 3 Ferncroft Street, Grafton, Auckland 1010
Country 139534 0
New Zealand
Phone 139534 0
+64 21 548 371
Fax 139534 0
Email 139534 0
[email protected]
Contact person for public queries
Name 139535 0
Ms. Carole Ann Moore
Address 139535 0
Bluejay Therapeutics, Inc., 255 Shoreline Drive, Suite 450 Redwood City CA 94065
Country 139535 0
United States of America
Phone 139535 0
+1 650 796 5003
Fax 139535 0
Email 139535 0
[email protected]
Contact person for scientific queries
Name 139536 0
Jenny Stanton, PharmD
Address 139536 0
Bluejay Therapeutics, Inc., 255 Shoreline Drive, Suite 450 Redwood City CA 94065
Country 139536 0
United States of America
Phone 139536 0
+1 650 504 5212
Fax 139536 0
Email 139536 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.