HepB mAb19 for Chronic Hepatitis B

Recruiting at 1 trial location

Overseen By Marina Caskey, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Rockefeller University

Must be taking: Nucleos(t)ide analogs

Must not be taking: Systemic corticosteroids, Immunosuppressive

Disqualifiers: Advanced fibrosis, HIV, HCV, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

37 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HepB mAb19, a monoclonal antibody designed to combat chronic hepatitis B. The study aims to determine the safety of HepB mAb19, its movement through the body, and its effectiveness in reducing the virus in individuals already on nucleos(t)ide analog therapy. Participants will receive either a dose of HepB mAb19 or a placebo (a harmless substitute) for comparison. Ideal candidates have had hepatitis B for at least six months and are stable on existing hepatitis B medication. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Do I need to stop my current medications for the trial?

The trial requires participants to continue their current HBV-active nucleos(t)ide therapy without changes for at least 3 months before joining. The protocol does not specify if other medications need to be stopped.

Is there any evidence suggesting that HepB mAb19 is likely to be safe for humans?

Research has shown that HepB mAb19 is under study to determine its safety for humans. This Phase 1 trial focuses on testing the treatment's safety at various dose levels. As this is the first test of HepB mAb19 in humans, detailed safety information is not yet available.

Phase 1 trials prioritize safety by starting with small doses and gradually increasing them. This method helps researchers identify side effects and assess how well participants tolerate the treatment. Notably, since this treatment involves an antibody, and antibodies are often well-tolerated in other medical contexts, this is encouraging.

If this trial finds HepB mAb19 to be safe, it will advance to further studies with more participants. These future studies will provide additional information on both safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about HepB mAb19 for treating chronic hepatitis B because it represents a novel approach compared to the current standard of care. While most existing treatments, like antiviral drugs, work by suppressing the virus, HepB mAb19 is a monoclonal antibody designed to target and neutralize the virus directly. This targeted action could potentially lead to improved outcomes with fewer side effects. Additionally, the intravenous delivery of HepB mAb19 offers a new method of administration that might provide more consistent dosing and enhanced efficacy.

What evidence suggests that HepB mAb19 might be an effective treatment for chronic hepatitis B?

Research has shown that HepB mAb19, which participants in this trial may receive, could be a promising treatment for chronic Hepatitis B. This treatment uses a monoclonal antibody to target a part of the virus, helping to stop its spread. Early signs suggest that these antibodies can help fight Hepatitis B infections. Although antibodies alone might not completely eliminate the virus, combining them with other treatments could enhance their effectiveness. Studies on similar treatments support the potential of HepB mAb19 to benefit people with chronic Hepatitis B. ^{1 2 3 6 7}

Who Is on the Research Team?

Marina Caskey, MD

Principal Investigator

The Rockefeller University

Are You a Good Fit for This Trial?

Adults aged 18-70 with chronic Hepatitis B on nucleos(t)ide therapy for at least 6 months can join. They must not be pregnant, agree to use contraception, and have a stable viral load. Excluded are those with severe allergies, heart disease, recent acute infections, advanced liver fibrosis or cancerous liver lesions.

Inclusion Criteria

I have been on stable hepatitis B treatment for at least 6 months.

Negative serum or urine pregnancy test at screening and on day 0 for participants who can become pregnant

My partner is sterile, confirmed by tests, and is my only partner.

Exclusion Criteria

HIV-1, HCV or hepatitis delta virus infection within 12 months from entry or done at screen

I haven't taken steroids, immunosuppressants, or certain cancer drugs in the last 6 months.

Confirmed significant allergic reactions against any drug, monoclonal antibody or vaccine, or multiple drug allergies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intravenous infusion of HepB mAb19 or placebo at one of four increasing dose levels

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, pharmacokinetics, and antiviral activity for 48 weeks after infusion

48 weeks

What Are the Treatments Tested in This Trial?

Interventions

• HepB mAb19

Trial Overview The trial is testing HepB mAb19, an experimental antibody targeting the hepatitis B virus in patients already on standard treatment. It's compared against a placebo (sterile saline). The study will look at safety and how well it works to control the virus.

How Is the Trial Designed?

Group I: Group 5: Maximum tolerated dose, IV Experimental Treatment 1 Intervention

Single intravenous infusion of HepB mAb19, dosed at the MTD

Group II: Group 4a: HepB mAb19 30 mg/kg, IV Experimental Treatment 1 Intervention

Single intravenous infusion of HepB mAb19, dosed at 30 mg/kg.

Group III: Group 3a: HepB mAb19 10 mg/kg, IV Experimental Treatment 1 Intervention

Single intravenous infusion of HepB mAb19, dosed at 10 mg/kg.

Group IV: Group 2a: HepB mAb19 3 mg/kg, IV Experimental Treatment 1 Intervention

Single intravenous infusion of HepB mAb19, dosed at 3 mg/kg.

Group V: Group 1a: HepB mAb19 1 mg/kg, IV Experimental Treatment 1 Intervention

Single intravenous infusion of HepB mAb19, dosed at 1 mg/kg.

Group VI: Group 2b: Placebo 3 mg/kg, IV Placebo Group 1 Intervention

Single intravenous infusion of placebo - normal saline, dosed at 3 mg/kg.

Group VII: Group 1b: Placebo 1 mg/kg, IV Placebo Group 1 Intervention

Single intravenous infusion of placebo - normal saline, dosed at 1 mg/kg.

Group VIII: Group 4b: Placebo 30 mg/kg, IV Placebo Group 1 Intervention

Single intravenous infusion of placebo - normal saline, dosed at 30 mg/kg.

Group IX: Group 3b: Placebo 10 mg/kg, IV Placebo Group 1 Intervention

Single intravenous infusion of placebo - normal saline, dosed at 10 mg/kg.

Who Is Running the Clinical Trial?

Rockefeller University

Lead Sponsor

Trials

162

Recruited

16,700+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

The Hepatitis A Inactivated and Hepatitis B Recombinant Vaccine (HEPAB), approved by the FDA in May 2001, received 305 reports of adverse events from May 2001 to September 2003, with most being non-serious like local reactions and constitutional symptoms.

Serious adverse events were reported, but a thorough review found no clear causal relationship with the vaccine, aside from injection site reactions and some allergic responses, indicating that HEPAB is generally safe for immunization in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events after hepatitis A B combination vaccine. Woo, EJ., Miller, NB., Ball, R.[2006]

In a study involving 43,618 Alaska natives who received 101,360 doses of the hepatitis B vaccine, only 39 individuals reported possible adverse reactions, indicating a low incidence of serious side effects.

The most common adverse reactions were mild and included prolonged myalgia/arthralgia, skin rashes, and dizziness, with no increased risk of Guillain-Barré syndrome found among vaccine recipients, supporting the vaccine's overall safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of adverse reactions to hepatitis B vaccine in 43,618 persons. McMahon, BJ., Helminiak, C., Wainwright, RB., et al.[2019]

Out of 1771 neonatal death reports following Hepatitis B vaccination, only 18 deaths were identified, suggesting a very low incidence of fatalities associated with the vaccine among neonates.

The majority of the autopsied cases (12 out of 17) were attributed to sudden infant death syndrome, indicating that there is no clear causal link between HepB vaccination and neonatal deaths, especially given the extensive use of the vaccine in over 86 million doses since 1991.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neonatal deaths after hepatitis B vaccine: the vaccine adverse event reporting system, 1991-1998. Niu, MT., Salive, ME., Ellenberg, SS.[2019]

A total of 20,231 adverse event reports were received following hepatitis B vaccinations from 2005 to 2015, with the most common side effects being dizziness and nausea for single antigen vaccines, and fever and injection site erythema for combination vaccines.

The review found no new or unexpected safety concerns with the current hepatitis B vaccines, but highlighted the need for improved training for healthcare providers to prevent vaccination errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of currently licensed hepatitis B surface antigen vaccines in the United States, Vaccine Adverse Event Reporting System (VAERS), 2005-2015. Haber, P., Moro, PL., Ng, C., et al.[2018]

The recombinant hepatitis B vaccine is generally considered safe and effective in preventing hepatitis B infection, which is a major cause of liver disease worldwide, but it may contain components that could be linked to autoimmune diseases in susceptible individuals.

Despite the potential risks, the overall benefits of the hepatitis B vaccine outweigh its risks, and it is important for patients and physicians to discuss these factors when considering vaccination, while also encouraging reporting of any adverse reactions for further research and safety improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of hepatitis B vaccination. Geier, MR., Geier, DA., Zahalsky, AC.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05856890

HepB mAb19 in Individuals With Chronic Hepatitis B Infection This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate the safety, pharmacokinetics and antiviral activity of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06668727

Safety and Antiviral Activity of a Monoclonal Hepatitis B ... This study aims to evaluate the safety, maximal tolerated dose, pharmacokinetics (PK) and antiviral effects of a highly potent neutralizing ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0166354224001025

Current and future use of antibody-based passive immunity ... Antibodies play a major role in resolution of HBV infection. Neutralization alone is likely not sufficient to clear the viral reservoir.

4. policylab.us policylab.us/clinical-trials/l/conditions/hepatitis-b

Hepatitis B Clinical Trials - Policy Lab A listing of 13 Hepatitis B clinical trials actively recruiting volunteers for paid trials and research studies in various therapeutic areas.

5. withpower.com withpower.com/clinical-trials/for-hepatitis-b?page=2

Top Hepatitis B Clinical Trials | Power HepB mAb19 for Chronic Hepatitis B. New York, New York. This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate ...

6. synapse.patsnap.com synapse.patsnap.com/drug/8b527ac422984e0889e32c3a7f87a54c

HepB mAb19 - Drug Targets, Indications, Patents Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a First-in-human Phase 1, Placebo-controlled, Single Dose Escalation Clinical Trial in ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9945514/

Safety profile, antiviral capacity, and liver protection of a ... The present study is the first to exhibit long-term follow-up data of a finite immune therapy for CHB that is safe and endowed with potent antiviral and liver- ...