NCT05856890 · Rockefeller University
HepB mAb19 in Individuals With Chronic Hepatitis B Infection
What this study is about
This is a first-in-human, compared against an inactive treatment, single dose, gradually increasing doses phase 1 study to evaluate the safety, how the drug moves through the body 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).
View original scientific description
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).
Interventions
BIOLOGICAL
HepB mAb19
HepB mAb19 is a human mAb of IgG1kappa isotype that specifically binds to the "a" determinant of the extracellular loop of the HBV surface antigen (HBsAg).
OTHER
Sterile Saline
Placebo will be normal sterile saline (NaCl 0.9%).
Primary outcome measures
Rate and severity of solicited adverse events that are Grade 2 or above within 2 weeks after administration.
Time frame: 2 weeks
The occurrence of solicited AEs will be assessed 2 weeks after IP administration.
Rate and severity of treatment-emerging unsolicited adverse events that are Grade 2 or above (including confirmed laboratory abnormalities) within 2, 12, 24 and 48 weeks after administration.
Time frame: 48 weeks
The occurrence of treatment-emerging AEs will be assessed after IP administration
Rate and severity of participants with serious adverse events (SAEs) throughout the study period that are considered related to investigational product and the duration of those SAEs.
Time frame: 48 weeks
The occurrence of SAEs will be assessed after IP administration
Rate and severity of participants with potential immune complex disease (ICD) throughout the study period following investigational product (IP) administration.
Time frame: 48 weeks
The occurrence of immune complex disease will be assessed after IP administration
Changes in AST within 2,12, 24 and 48 weeks after administration.
Time frame: 48 weeks
Changes in AST will be assessed after IP administration
Changes in ALT within 2,12, 24 and 48 weeks after administration
Time frame: 48 weeks
Changes in ALT will be assessed after IP administration
Changes in alkaline phosphatase within 2,12, 24 and 48 weeks after administration
Time frame: 48 weeks
Changes in alkaline phosphatase will be assessed after IP administration
Changes in bilirubin within 2,12, 24 and 48 weeks after administration
Time frame: 48 weeks
Changes in bilirubin will be assessed after IP administration
Changes in albumin within 2,12, 24 and 48 weeks after administration
Time frame: 48 weeks
Changes in albumin will be assessed after IP administration
Elimination half-life of HepB mAb19
Time frame: 48 weeks
Elimination half-life (t1/2) will be assessed after IP administration
Clearance (CL/F) of HepB mAb19
Time frame: 48 weeks
Clearance (CL/F) will be assessed after IP administration
Volume of Distribution (Vz/F) of HepB mAb19
Time frame: 48 weeks
Volume of Distribution (Vz/F) will be assessed after IP administration
Area under the curve (AUC) of HepB mAb19
Time frame: 48 weeks
Area under the curve (AUC) will be assessed after IP administration
Decay Curve of HepB mAb19
Time frame: 48 weeks
Decay Curve will be assessed after IP administration
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New York, New York
Collaborators
NYU Langone Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 2, 2026 · Source of record for eligibility and locations