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RECRUITING
NCT05856890
PHASE1

HepB mAb19 in Individuals With Chronic Hepatitis B Infection

Sponsor: Rockefeller University

View on ClinicalTrials.gov

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).

Official title: A Phase 1, Placebo-controlled, Dose-escalation Study of the Safety, Pharmacokinetics, and Antiviral Activity of a Potent Neutralizing Monoclonal Antibody in Individuals With Chronic Hepatitis B Infection

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2023-08-07

Completion Date

2028-03-30

Last Updated

2026-02-02

Healthy Volunteers

No

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%).

Locations (2)

NYU Langone Health

New York, New York, United States

The Rockefeller University

New York, New York, United States