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NCT05856890 · ClinicalTrials.gov registry record · Phase 1

HepB mAb19 in Individuals With Chronic Hepatitis B Infection

A Phase 1 study of Hepatitis B and Hepatitis b Virus, sponsored by Rockefeller University.

Recruiting
Registry status
Phase 1
Development phase
37
Enrollment target
2
Study locations

NCT05856890 is a Phase 1 study of Hepatitis B and Hepatitis b Virus that is actively recruiting participants, run by Rockefeller University. The registered enrollment target is 37 participants, below the 1,627-participant average among 32 other Hepatitis B trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT05856890, a Phase 1 study of Hepatitis B and Hepatitis b Virus, is actively recruiting participants, sponsored by Rockefeller University.

RECRUITING
Registry status
Phase 1
Development phase
37 participants
Enrollment target
2
Study locations

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

Hepatitis B Hepatitis b Virus

Interventions

  • BIOLOGICAL HepB mAb19
  • OTHER Sterile Saline

Study Locations (2)

New York

  • NYU Langone Health - New York
  • The Rockefeller University - New York

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2023-08-07
Est. Completion 2028-03-30
Phase Phase 1

Sponsor

Rockefeller University

117 total trials

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What the Registry Record Tells You About NCT05856890

The ClinicalTrials.gov registry entry for NCT05856890 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,627-participant average among 32 other Hepatitis B trials with a reported enrollment target (98% lower). The listed sponsor is Rockefeller University, which has 117 total studies on file at ClinicalTrials.gov.

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.

NCT05856890 reports 2 study locations spanning 1 distinct geographic area - top geographies include New York.

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.

What interventions are being tested in trial NCT05856890?

The interventions under investigation include: HepB mAb19 (BIOLOGICAL), Sterile Saline (OTHER).

Who is sponsoring clinical trial NCT05856890?

This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.