CompletedPhase 1ACTRN12623000078651

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of BJT-778 in Subjects with Chronic HBV Infection (CHB).

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 2 conducted in Subjects with Chronic Hepatitis B Infection

Sponsor

Bluejay Therapeutics Inc.

Enrollment

40 participants

Start Date

May 2, 2023

Study Type

Interventional

Conditions

Chronic Hepatitis B Virus (HBV) Infection

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 CHB. Hepatitis delta virus (HDV) is the causative agent of chronic hepatitis delta (CHD), 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 anti HBV and anti HDV benefits by neutralizing and clearing HBV and HDV virions as well as by depleting HBsAg containing subviral particles, which may help 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, pharmacokinetics and antiviral activity of BJT-778 in patients with CHB.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria11

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 between 18 and 70 years of age
BMI 18-40 kg/m2
Chronic HBV infection greater than or equal to 6 months (e.g., positive for serum HBsAg greater than or equal to 6 months)
Plasma HBV DNA less than 100 IU/ml at Screening
On nucleos(t)ide analogs
Qualitative HBsAg level criteria at Screening by Cohort/group:
Cohort B: lower HBsAg levels (less than 3000 IU/mL)
Cohort C: higher HBsAg levels (greater than 3000 IU/mL)
Females: Non-pregnant and non-lactating; surgically sterile, post-menopausal or, if engaged in sexual relations of childbearing 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 child-bearing 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.

Exclusion Criteria14

Evidence of cirrhosis
History of decompensated liver disease
History of liver disease other than Hepatitis B
Received solid organ or bone marrow transplant
Currently taking, or took within 1 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
Clinically significant abnormalities aside from chronic HBV infection in medical history (e.g., previous acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening, uncontrolled diabetes) or physical examination
History of bleeding diathesis or coagulopathy
History of, or suspected presence of vasculitis
History of extrahepatic disorders possibly related to HBV immune complexes (e.g., glomerulonephritis, polyarteritis nodosa)
Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated
Treatment with a different investigational drug other than BJT-778, biological agent, or device within 4 weeks of screening or 5 half-lives of Study Drug, whichever is longer.
History of drug abuse/addiction within 6 months (except cannabis) of Screening or positive urine drug Screen (excluding physician-prescribed drugs and cannabis)
Unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator
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.

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Interventions

BJT-778 is being developed as a potent, selective neutralizing monoclonal antibody for the treatment of Chronic Hepatitis B Virus Infection (CHB). Dosing of Groups B1 (Dose 1) may initiate when the Dose 1 is deemed safe in healthy volunteers (Group A1) by the SRC at the Day 14 safety review. Dose escalation to Dose 2 (Groups B2, C2) may proceed when the Day 14 safety review of the healthy volunteers at the Dose 2 (Group A2) and the Dose 1 in HBV-infected subjects (all subjects from B1) have determined to have acceptable safety profiles. The SRC will also incorporate available longer-term safety, efficacy, and PK data from all current and prior dosing groups into the decision making. Dose escalation to the Optional Dose 3 in each group (B3, C3) may proceed once at least 14-day safety is established in the healthy volunteers at Dose 3 (Group A3) and 14-day safety is established at Dose 3 of the respective cohorts (B2, C2) per SRC review. Subjects will be monitored with serial vitals, ECGs, safety laboratory assessments, and AEs recording. Doses of BJT-778 in Cohort B and C include: Cohort B – Subjects with CHB with lower HBsAg levels: • B1) Dose 1 x 1 subcutaneously (SC) • B2) Dose 2 x 1 SC • B3) Optional Dose 3 x 1 SC Cohort C – Subjects with CHB with higher HBsAg levels: • C2) Dose 2 x 1 SC • C3) Optional Dose 3 x 1 SC Doses fall within the range of 75mg to 900mg and the exact doses will be disclosed after IP restrictions are met.