RecruitingPhase 1NCT05856890

HepB mAb19 in Individuals With Chronic Hepatitis B Infection

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

Sponsor

Rockefeller University

Enrollment

37 participants

Start Date

Aug 7, 2023

Study Type

INTERVENTIONAL

Conditions

Hepatitis B Hepatitis B Virus

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).

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called HepB mAb19 and Sterile Saline for people with hepatitis b and hepatitis b virus. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHepB 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).

OTHERSterile Saline

Placebo will be normal sterile saline (NaCl 0.9%).