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HepB mAb19 in Individuals With Chronic Hepatitis B Infection

NCT05856890 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-02-02

No results posted yet for this 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

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%).

Sponsors & Collaborators

Principal Investigators

  • Marina Caskey, MD · The Rockefeller University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-07
Primary Completion
2027-12-01
Completion
2028-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05856890 on ClinicalTrials.gov