A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod in Subjects with Chronic Hepatitis B Infection
A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod Alone and in Combinations in Subjects with Chronic Hepatitis B Infection -Part B
Bluejay Therapeutics, Inc
80 participants
Jun 6, 2025
Interventional
Conditions
Summary
This is a Phase 1b study to evaluate the safety and tolerability, PK/PD, and antiviral activity/efficacy of cavrotolimod and cavrotolimod-containing combinations in CHB infected subjects who are on nucleos(t)ide therapy. Cavrotolimod ± BJT-778 is being developed to address the high unmet medical need with possible benefits for participants with Chronic Hepatis B virus infection (CHB). This study will enroll non-cirrhotic, chronic hepatitis B (CHB) infected adults aged 18-65 years of age, inclusive, on nucleos(t)ide therapy. Part B will evaluate open-label, cavrotolimod plus BJT-778, HBsAg monoclonal antibody, in combination. Thi sStudy duration of Part B: Up to 52 weeks (up to 4 weeks for Screening, 24 weeks for treatment, and 12 to 24 weeks for follow up).
Eligibility
Inclusion Criteria29
- Male or female adults between 18 and 65 years of age, inclusive
- Chronic HBV infection greater than or equal to 6 months (e.g., positive for serum HBsAg greater than or equal to 6 months)
- Taking a commercially available nucleos(t)ide analogs for at Least 2 months prior to Screening, and
- willing to remain on stable treatment for the duration of the study, unless they achieve nucleos(t)ide.
- stopping criteria.
- HBV DNA less than 100 IU/mL in blood at Screening
- HBsAg at Screening:
- a. Part B Cohort 1: greater than LLOO to 3000 IU/mL.
- In Part B, optional Cohorts and expansion subjects/arm/cohort (including Cohort 1), the upper Limit of 3000 IU/mL may be removed based on emerging data.
- a. Presence of anti-thyroid antibodies (anti-thyroid-stimulating hormone receptor ITSHRI, anti thyroglobulin ITGI, or anti- thyroid peroxidase [TPO])
- b. Abnormal thyroid stimulating hormone (TSH)
- c. ANA greater than 1160
- d. ALT or aspartate aminotransferase (AST) greater than 2 upper Limit of normal (ULN)
- e. Total bilirubin greater than 1.2 ULN, except for subjects with Gilbert's (normal direct bilirubin)
- f. Serum albumin less than .5 g/dL
- g. International normalized ratio (INR) greater than 1.2
- h. Platelet count less than 140 K/mm3
- i. Hemoglobin Less than 12.0 g/dL for males and <11.0 g/dL for females
- j. Absolute neutrophil count less than 1000/mm3
- k. Estimated glomerular fltration rate lass than 50 mL/min/1.73 m2 by Cockcroft-Gualt
- 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 <340 msec (Fridericia's correction)
- 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.
- Treatment with an investigational drug, biological agent or device within 4 weeks or 5 half-lives prior to Screening, whichever is longer.
- History of 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)
- History of drug abuse/addiction within 6 months of Screening (except cannabis)
- Have any other 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
Exclusion Criteria11
- Pregnant or nursing females
- Male or female subjects of childbearing potential unwilling to comply with contraception requirements during the study
- Fibroscan greater than or equal to 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 variceal bleeding
- Presence of Liver disease, not including chronic HBV infection, such as nonalcoholic steatohepatitis (NASH), alcohol-associated hepatitis, cholestatic Liver disease, other viral (e.g., HCV or HDV) or non-viral hepatitis that has the potential to impact interpretation of data. Exceptions to this criterion 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.
- Positive for HIV, HDV, or HCV infection at Screening
- Received solid organ or bone marrow transplant
- Chronic systemic immunosuppressive therapy (e.g., prednisone) within 1 month of Screening or require the use of during the study.
- Prior or current history of hepatocellular carcinoma (HCC) or suspected HCC as evidenced by screening alpha-fetoprotein greater than or equal to 20 ng/mL
- History of hypersensitivity to any of the components in the cavrotolimod formulation or severe reactions to injections
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Interventions
Investigational Product (IP): Cavrotolimod and BJT-778 Dosage Form: Vial Method of administration: Sub cutaneous (SC) injection Dose: Cavrotolimod will be supplied as 2mL vial and BJT-778 will be supplied as 6 ml glass vial. The study consists of two parts (Part A and Part B). This registration details are for Part B. Part B will evaluate open-label, cavrotolimod plus BJT-778, a HBsAg (Hepatitis B surface antigen) monoclonal antibody, in combination. Part B may initiate once a cavrotolimod dose has been deemed safe in Part A and will enroll upto 80 subjects. Study consists of 3 cohorts and each cohort/arm will enroll 10-15 subjects. - Cohort 1- Arm 1 and Expansion Arm 1a, Cavrotolimod (less than equal to 24 mg) for 4 weeks plus BJT-778 (less than equal to 900mg) SC every 4 weeks for 6 months. Arm 2 and Expanded Arm 2a, 4-week lead-in of BJT-778 (less than equal to 900mg) SC every 4 weeks then cavrotolimod (less than equal to 24 mg) for 4 weeks plus BJT778 for 5 months. - Optional Cohort 2- Arm 1 and Expansion 1a, Cavrotolimod (less than equal to 24 mg) for 4 weeks plus BJT-778 (less than equal to 900mg) SC every 4 weeks for 6 months - Optional Cohort 3- Arm 1 and Expansion 1a, 4-week lead-in of BJT-778 (less than equal to 900mg) SC every 4 weeks then cavrotolimod (less than equal to 24 mg) for 4 weeks plus BJT-778 for 5 months. Subjects will be followed for 12 weeks after the last dose of study medications. Subjects who achieve HBsAg loss {HBsAg <LLOQ (lower limit of quantification)} at the end of follow up will continue to be followed for an additional 12 weeks (total 24 weeks of follow up). Optional cohorts 2 and 3 may be included to explore additional dose levels and/or dosing regimens. Optional cohorts 2 and 3 may also be included to extend an existing dose level and/or dosing regimens for the purposes of gathering further information at that dose level. The number of subjects in a dose cohort in either Part A or B can be extended to gather further information on a dosing regimen. Expansion arm enrollment may overlap with original arm conduct; however, expansion arms will only be opened once original arm has completed enrollment. The maximum expansion is 100% of the original cohort size at the select dose level, however, all will receive open label cavrotolimod. Adherence is not monitored as cavrotolimod will be injected by the site staff.
Locations(6)
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ACTRN12624000809538