New antibody shot aimed at taming hepatitis b
NCT ID NCT05856890
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a single dose of a new antibody (HepB mAb19) in 37 adults with chronic hepatitis B who are already on standard antiviral pills. The main goal is to see if the antibody is safe and how long it stays in the body. It is an early-phase trial, so it focuses on safety and drug levels, not yet on curing the infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 37 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18 to 70; * HBV infection confirmed by positive HBsAg for \>/= 6 months; * On HBV-active nucleos(t)ide therapy for \>/= 6 months without change in NRTI in the previous 3 months; * The following laboratory values within 49 days from study entry (day 0): * HBV DNA below lower limit of quantification; * HBsAg \> 10 IU/mL; * HBs antibody negative; * Ability and willingness to provide informed consent; * For participants who can become pregnant (i.e., participants who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy or bilateral salpingectomy), negative serum or urine pregnancy test at screening and on day 0 (study entry). * Participants who can become pregnant must agree to use two methods of contraception. * Partner sterilization with documentation of azoospermia prior to the participant's entry into the study, and this partner is the sole partner for that participant. The documentation of partner sterility can come from the site personnel's review of medical records or medical history interview provided by the participant or the partner. Self-reported documentation of reproductive potential should be entered in the source documents. * Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms from 10 days prior to study entry and during study follow up to avoid impregnating a partner who can get pregnant. Exclusion Criteria: \- Clinical symptoms, imaging studies or liver histology suggestive of advanced fibrosis (exclude fibrosis grade 3 and 4 by FibroScan (Fibroscan®\< 9 kpa) within 12 months from entry or done at the pre-infusion visit. Note: If FibroScan results from within 12 months are not available, imaging will be performed at the pre-infusion visit. * Presence of a LI-RADS4 or 5 liver lesion on imaging within 12 months from entry or done at pre-infusion visit, if prior results not available. * Alpha fetoprotein \> 20 ng/ml Note: AFP above normal but \< 20 is acceptable for entry if earlier AFP levels (older than 6 months) are within normal range and imaging is negative in last 3 months). * HIV-1, HCV or hepatitis delta virus infection within 12 months from entry or done at screen, if prior results not available. * History of hematopoietic stem cell transplant or solid organ transplant; * Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, monoclonal antibody or vaccine, or multiple drug allergies (non-active hay fever is acceptable); * History of cardiovascular disease (e.g., cardiac insufficiency, coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome, family history of sudden death); * History or presence of clinically significant ECG abnormalities based on the average of the triplicate ECG recordings (e.g., QT corrected for heart rate using the Fridericia's correction factor \[QTcF\] \> 450 ms for males and QTcF \> 470 ms for females); * History of systemic corticosteroids, immunosuppressive anti-cancer, systemic interferons or interleukins within the last 6 months; * History of chronic liver disease from another cause, immune complex disease, or autoimmune diseases that in the opinion of the investigator would preclude participation. * Any significant acute infection (e.g. influenza, COVID-19) or any other clinically significant illness within 2 weeks prior to Day 0. * Laboratory abnormalities in the parameters listed below: * Absolute neutrophil count \< 1,000 /mm3 * Hemoglobin \< 10 gm/dL * Platelet count \< 150,000 /mm3 * ALT \> 2.0 x ULN * AST \> 2.0 x ULN * Total bilirubin \> 1.5 ULN (except individuals with known Gilbert's) * Albumin \< 3.5 gm/dL * Calculated creatinine clearance \< 70 mL/min (using the Cockcroft Gault formula). * INR \>/= 1.2 * Pregnancy or lactation; * Any vaccination within 14 days prior to IP administration; * Receipt of anti-HBV mAb therapy of any kind in the past (including HBIG); * Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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The Rockefeller University
RECRUITINGNew York, New York, 10065, United States
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Other studies related to the condition(s) this trial covers.
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