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
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.
Bluejay Therapeutics, Inc
50 participants
May 30, 2025
Interventional
Conditions
Summary
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 or placebo 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). BJT-628 is an oral small molecule hepatitis B transcript inhibitor being developed for the treatment of Chronic Hepatitis B (CHB) and Chronic Hepatitis D (CHD). This study will enrol patients with Chronic HBV infection and chronic hepatitis D infection in age between 18-65. In chronic hepatitis B (CHB) and chronic hepatitis D (CHD) subjects, BJT-628 will be safe and well tolerated, demonstrating favorable pharmacokinetics, and preliminary antiviral activity in CHB subjects as evidence by a reduction from baseline in HBsAg levels over 28 days.
Eligibility
Inclusion Criteria18
- 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 and female adults.
- 18 to 65 years of age, inclusive
- 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)
- HBsAg > Lower limit of quantification (LLOQ) at Screening
- HBV DNA LLOQ at Screening
- 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)
- 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)
- History of bleeding diathesis or coagulopathy
Exclusion Criteria25
- Pregnant or lactating females
- Male or female subjects of childbearing potential unwilling to comply with contraception requirements during the study.
- History or presence of central neurological or peripheral neuropathy disease from physical examination
- Family history of peripheral neuropathy
- History of or current migraine headaches
- Diabetes
- 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
- 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
- History of hypersensitivity to any of the components in the BJT-628 formulation
- 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)
- History of drug abuse/addiction within one year of Screening (except cannabis)
- 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
- Unwillingness to comply with study procedures, including follow up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator
- 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)
- Fibroscan >8.5 kPa within 1 year of Screening
- History of and/or current decompensated liver disease as evidenced by ascites, hepatic encephalopathy, and/or gastric or esophageal varices
- Received solid organ or bone marrow transplant
- 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.
- Diagnosed hepatocellular carcinoma (HCC) or suspected HCC as evidenced by screening alpha-fetoprotein more than equal to 20 ng/mL
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Interventions
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.
Locations(3)
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ACTRN12625000281493