Actively Recruiting
HepB mAb19 in Individuals With Chronic Hepatitis B Infection
Led by Rockefeller University · Updated on 2026-02-02
37
Participants Needed
2
Research Sites
242 weeks
Total Duration
On this page
Sponsors
R
Rockefeller University
Lead Sponsor
N
NYU Langone Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate the safety, pharmacokinetics and antiviral activity of a highly potent neutralizing anti-HBV monoclonal antibody (mAb), HepB mAb19, which targets the S-protein in individuals with chronic hepatitis B (CHB) on nucleos(t)ide analog therapy (NRTI).
CONDITIONS
Official Title
HepB mAb19 in Individuals With Chronic Hepatitis B Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years
- Chronic hepatitis B infection confirmed by positive HBsAg for 6 months or more
- On HBV-active nucleos(t)ide therapy for at least 6 months with no change in therapy during the previous 3 months
- HBV DNA below the lower limit of quantification within 49 days before study entry
- HBsAg level greater than 10 IU/mL within 49 days before study entry
- Negative HBs antibody within 49 days before study entry
- Ability and willingness to provide informed consent
- For participants who can become pregnant, negative serum or urine pregnancy test at screening and study entry
- Participants who can become pregnant must agree to use two methods of contraception
- Partner sterilization with documented azoospermia if partner is the sole sexual partner
- Participants who can impregnate a partner must agree to use condoms from 10 days prior to study entry and during follow-up
You will not qualify if you...
- Clinical symptoms, imaging or liver histology indicating advanced fibrosis (FibroScan < 9 kPa within 12 months or at pre-infusion visit)
- Presence of LI-RADS4 or 5 liver lesion on imaging within 12 months or at pre-infusion visit
- Alpha fetoprotein level greater than 20 ng/ml unless earlier levels are normal and recent imaging is negative
- Infection with HIV-1, HCV, or hepatitis delta virus within 12 months or at screening
- History of hematopoietic stem cell or solid organ transplant
- Significant allergic reactions to drugs, monoclonal antibodies or vaccines, or multiple drug allergies (excluding non-active hay fever)
- History of cardiovascular disease including cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, or family history of congenital long QT syndrome or sudden death
- Clinically significant ECG abnormalities (QTcF > 450 ms for males, > 470 ms for females)
- Use of systemic corticosteroids, immunosuppressive anti-cancer therapies, systemic interferons or interleukins within the last 6 months
- Chronic liver disease from other causes, immune complex disease, or autoimmune diseases that would preclude participation
- Significant acute infections or other serious illness within 2 weeks prior to study entry
- Laboratory abnormalities including neutrophil count < 1,000/mm3, hemoglobin < 10 g/dL, platelet count < 150,000/mm3, ALT or AST > 2 times upper limit of normal, total bilirubin > 1.5 times upper limit of normal (except Gilbert's), albumin < 3.5 g/dL, creatinine clearance < 70 mL/min, INR ≥ 1.2
- Pregnancy or lactation
- Vaccination within 14 days prior to investigational product administration
- Previous receipt of anti-HBV monoclonal antibody therapy including HBIG
- Participation in another investigational product study currently or within past 12 weeks, or expected participation during this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
2
The Rockefeller University
New York, New York, United States, 10065
Actively Recruiting
Research Team
R
Recruitment Specialist
CONTACT
M
Marina Caskey, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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