A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-778 in Healthy Volunteers.
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 1 conducted in Healthy Volunteers
Bluejay Therapeutics Inc
32 participants
Feb 17, 2023
Interventional
Conditions
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 Chronic HBV Infection (CHB). Hepatitis delta virus (HDV) is the causative agent of 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 antiviral benefits by neutralizing and clearing HBV and HDV virions as well as by depleting HBsAg containing subviral particles, which may help to 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 and pharmacokinetics of BJT-778 in Healthy volunteers.
Eligibility
Inclusion Criteria7
- Cohort A (Healthy Volunteers)
- 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, age 18 to 55 years
- BMI 18 to 35 kg/m2
- Females: Non-pregnant and non-lactating; surgically sterile (e.g., tubal ligation, hysterectomy, bilateral salpingectomy, bilateral oophorectomy), post-menopausal (defined as 12 months of spontaneous amenorrhea in females less than 55 years of age or, in females less than or equal to 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and FSH levels in the postmenopausal range for the laboratory involved) or, if engaged in sexual relations of child-bearing 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 childbearing 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.
- In good health, in the judgement of investigator
Exclusion Criteria17
- Cohort A (Healthy Volunteers)
- Serious or severe chronic conditions requiring frequent medical intervention or continuous pharmacologic management
- Medical or social conditions that would potentially interfere with the subject’s ability to comply with the study visits
- History of severe drug hypersensitivity or severe allergic reaction
- History of or current 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)
- Significant drug abuse/addiction within 1 year of Screening (excluding cannabis), or a
- positive urine drug screen (except cannabis)
- Positive HBsAg, hepatitis C virus (HCV) antibody (Ab), or human immunodeficiency
- virus (HIV) Ab
- -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 less than 340 msec (Fridericia’s correction)
- Sustained supine systolic blood pressure (BP) of greater than 150 or less than90 mm Hg or supine diastolic BP of greater than 95 or less than50 mm Hg at Screening. The average of 2 assessments of BP will be used to exclude a subject
- Resting pulse rate at Screening of greater than 100 or less than 45.
- Donated or lost greater than 500 mL of blood within 60 days prior to enrollment into this study
- Active infection or febrile illness less than or equal to 14 days prior to Study Day 1
- Use of 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 post dosing
- Any clinically significant screening laboratory values outside of the normal limits
- Treatment with another investigational drug, biological agent, or device within 4 weeks of Screening or 5 half-lives of the investigational drug, whichever is longer
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
BJT-778 is being developed as a potent, selective neutralizing monoclonal antibody for the treatment of Chronic Hepatitis B Virus Infection (CHB) and Chronic Hepatitis D Virus Infection (CHD). In the healthy volunteers, the sentinel 2 subjects in each dosing group will be randomized 1:1 and following 24 hours of no safety events, the subsequent subjects will be enrolled 5:1 (final 6:2). Dose escalation may proceed to the next level when all the subjects in the preceding dose group have completed dosing and Day 14 safety evaluations and demonstrated an acceptable safety profile as determined by the Safety Review Committee (SRC), which will include the Investigators currently enrolling subjects, contract research organization (CRO) medical monitor and sponsor medical monitor (or designee). Subjects will be monitored with serial vitals, ECGs, safety laboratory assessments, and AEs recording. Doses of BJT-778 in Cohort A include: • A1) Dose 1 (75mg) x 1 subcutaneously (SC) • A2) Dose 2 (300mg) x 1 SC • A3) Dose 3 (900mg) x 1 SC • A4) Optional Dose (900mg) x 1 SC
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12623000075684