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Trial registered on ANZCTR


Registration number
ACTRN12624001003561
Ethics application status
Approved
Date submitted
22/07/2024
Date registered
16/08/2024
Date last updated
16/08/2024
Date data sharing statement initially provided
16/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of BJT-678 in Healthy volunteers
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.
Secondary ID [1] 312486 0
BJT-628-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis D Infection 334344 0
Chronic Hepatitis B Infection 334388 0
Condition category
Condition code
Infection 330991 330991 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Investigational Product (IP): BJT-628
Dosage Form: Capsules
Method of administration: Orally

The study consists of two parts (Part 1a and Part 1b). This registration details are for Part 1a. The Phase 1a portion of this study is a first-in-human (FIH), randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics of single (Part A) and multiple (Part B) ascending doses of BJT-628 in healthy adult volunteers (HV). Study will enroll 80 healthy volunteers.

Number of Participants:
Phase 1a: up to ~80 healthy volunteers, as follows:
• Part A: Up to ~48 subjects
• Part B: Up to ~32 subjects

Part A: Each SAD cohort will enroll 8 subjects (6 active to 2 placebo) with the first 2 subjects (randomized 1 active to 1 placebo) being enrolled 24 hours in advance of the rest of the cohort as a safety precaution.

Part B: Each cohort, below, will enroll 8 subjects (randomized 3 actives to 1 placebo) in a staggered fashion.

Part A (Phase 1a) will evaluate up to 5 single ascending dose (SAD) cohorts of BJT-628 or placebo and a food effect cohort. A single dose of BJT-628 or placebo will be administered orally the morning of Day 1, after a minimum 8-hour overnight fast. All subjects will be admitted for 5 days post-dose for close safety monitoring with discharge on Day 5. Subjects may be brought to the clinic 1 day prior to Study Day 1.
•Cohort 1: BJT-628 35 mg or placebo
• Cohort 2: BJT-628 (less than equal to 105 mg) or placebo
• Cohort 3- Period 1 Fasted: BJT-628 (less than equal to 315 mg) or placebo, then washout for less than equal to 7 days; Period 2 Fed: BJT-628 (less than equal to 315 mg) or placebo with a moderate fat meal. Each Period will dose on Day 1 and complete the same schedule of assessments. Period 1 Day 11 and 15 visits may be missed if subjects enter Period 2.
• Cohort 4: BJT-628 (less than equal to 945 mg) or placebo
• Cohort 5: BJT-628 (less than equal to 945 mg) or placebo. The cohort 4 and 5 have the same maximum dose as this this allows us the option to continue to dose escalate at a reasonable rate and have multiple options to do so, while indicating a maximum dose.

Part B (Phase 1a) will explore multiple ascending doses of BJT-628 or placebo, randomized 3:1 (up to 4 ascending dose cohorts) and administered orally once daily or every 12 hours for 14 days under fasted conditions.
-Cohort 1: BJT-628 (less than equal to 50% of the highest tolerated dose in Part A) or placebo
• Cohort 2: BJT-628 (less than equal to 3 x Cohort 1 dose) or placebo
• Cohort 3: BJT-628 (less than equal to 3 x Cohort 2 dose) or placebo
• Cohort 4: BJT-628 (less than equal to 3 x Cohort 3 dose) or placebo

Subjects will be followed for 14 days after the last dose of study drug. Adherence to intervention is monitored by the site staff. Part B may initiate when the first 3 cohorts’ fasted dose in Part A have been found to be safe and well tolerated based on safety follow-up of 7 days post-dose. The maximum dose evaluated in Part B will not exceed the highest tolerated dose evaluated in Part A.
Intervention code [1] 329024 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] 338776 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] 338776 0
-Adverse events monitored daily from screening to end of study (EOS) 2 weeks for SAD and 4 weeks for MAD post first dose administration.

- Safety Lab parameters will be monitored for SAD on screening, Day 1, Day 2, Day 5 and Day 15 for SAD cohort; for MAD on screening, Day1, Day 2 (blood chemistry), Day 5, Day 15 and Day 29 post first dose administration.
Secondary outcome [1] 437404 0
To evaluate the plasma pharmacokinetics (PK) of BJT-628 and metabolite BJT-338
Timepoint [1] 437404 0
Part A: (SAD): Day 1 and Cohort 3 period 2 Day 1 (Fed): 0 (pre-dose) and, 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours post first dose administration.
Part B (MAD): Days 1 and 15: 0 (Pre-dose) and 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, and 12 hours post dose; Pre-dose concentrations will also be obtained on days 2, 3, and 5 (for dose once daily) and on day 3 and 5 for dose every 12 hours,
Secondary outcome [2] 437405 0
To evaluate the effect of food on the plasma PK of BJT-628 and metabolite BJT-338
Timepoint [2] 437405 0
Part A: (SAD): Day 1 and Cohort 3 period 2 Day 1 (Fed): 0 (pre-dose) and, 15, 30 minutes, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, and 24 hours 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.
Phase 1a (Healthy Volunteers)
3. 18 to 60 years of age, inclusive
4. Body mass index (BMI) 18 to 35 kg/m2, inclusive
5. In good health, in the judgment of the Investigator
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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 greater 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 <340 msec (Fridericia’s correction)
13. Donated or lost >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
16. PHQ-9 questionnaire (administered by appropriately trained site staff) score greater than equal to 10
17. Serious or severe chronic conditions requiring frequent medical intervention or continuous pharmacologic management
18. Medical or social conditions that would potentially interfere with the subject’s ability to comply with study visits
19. History of severe drug hypersensitivity or severe allergic reaction
20. Positive HBsAg, hepatitis C virus (HCV) antibody (Ab), or human immunodeficiency virus (HIV) Ab
21. Sustained supine systolic blood pressure (BP) of >150 or <90 mm Hg or supine diastolic BP of >95 or <50 mm Hg at Screening. The average of 2 assessments of BP will be used to exclude a subject
22. Resting pulse rate at Screening of >100 or <45 beats per minute
23. Positive drug test at Screening (excluding physician-prescribed drugs and cannabis)
24. Use of regular 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 postdosing with the exception of oral or injectable contraceptives. Intermittent (as needed) medications that are not used daily (e.g., paracetamol, ibuprofen, calcium carbonate, etc.) are not exclusionary, even if taken within 14 days of dosing
25. Any clinically significant physical exam or vital sign findings, or screening laboratory values outside of the normal limits

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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/08/2024
Actual
Date of last participant enrolment
Anticipated
30/09/2025
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 26414 0
New Zealand
State/province [1] 26414 0
Auckland

Funding & Sponsors
Funding source category [1] 316906 0
Commercial sector/Industry
Name [1] 316906 0
Bluejay Therapeutics, Inc.
Country [1] 316906 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] 319155 0
None
Name [1] 319155 0
Address [1] 319155 0
Country [1] 319155 0
Other collaborator category [1] 283117 0
Other
Name [1] 283117 0
Novotech(Australia) Pty Limited
Address [1] 283117 0
Country [1] 283117 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315664 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 315664 0
Ethics committee country [1] 315664 0
New Zealand
Date submitted for ethics approval [1] 315664 0
03/07/2024
Approval date [1] 315664 0
06/08/2024
Ethics approval number [1] 315664 0

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

Contacts
Principal investigator
Name 135426 0
Prof Ed Gane
Address 135426 0
New Zealand Clinical Research, 3 Ferncroft Street, Grafton, Auckland 1010
Country 135426 0
New Zealand
Phone 135426 0
+64 21 548 371
Fax 135426 0
Email 135426 0
edgane@adhb.govt.nz
Contact person for public queries
Name 135427 0
Ms. Carole Ann Moore
Address 135427 0
Bluejay Therapeutics, Inc., 400 Concar Drive Suite 3-101 San Mateo, CA 94402
Country 135427 0
United States of America
Phone 135427 0
+1 650 796 5003
Fax 135427 0
Email 135427 0
cmoore@bluejaytx.com
Contact person for scientific queries
Name 135428 0
Jenny Stanton, PharmD
Address 135428 0
Bluejay Therapeutics, Inc., 400 Concar Drive Suite 3-101 San Mateo, CA 94402
Country 135428 0
United States of America
Phone 135428 0
+1 650 504 5212
Fax 135428 0
Email 135428 0
jstanton@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.