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HepB mAb19 in Individuals With Chronic Hepatitis B Infection
NCT05856890 · View on ClinicalTrials.gov ↗
Study Summary
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 Studied
Interventions
- BIOLOGICAL HepB mAb19
- OTHER Sterile Saline
Study Locations (2)
New York
- NYU Langone Health — New York
- The Rockefeller University — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2023-08-07 |
| Est. Completion | 2028-03-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05856890
The ClinicalTrials.gov registry entry for NCT05856890 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rockefeller University, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Hepatitis B appearing as the primary indexed condition, and to 2 interventions — of which HepB mAb19 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05856890 reports 2 study locations spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05856890 about?
NCT05856890 is a clinical study titled "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 a highly potent neutralizing anti-HBV monoclonal antibody (mAb), HepB mAb19, which targets the S-protein in individuals with chronic hepatitis B...
What is the current status of trial NCT05856890?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2023-08-07. Estimated completion is 2028-03-30.
What conditions does trial NCT05856890 study?
This clinical trial studies the following conditions: Hepatitis B, Hepatitis b Virus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05856890?
The interventions under investigation include: HepB mAb19 (BIOLOGICAL), Sterile Saline (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05856890?
This trial is sponsored by Rockefeller University, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05856890 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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