HepB mAb19 in Individuals With Chronic Hepatitis B Infection

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

The study has a dose escalation design. In Groups 1-4, eligible participants will be randomized at a 3:1 ratio to receive a single intravenous infusion of HepB mAb19 or placebo (normal saline) at one of four increasing dose levels (1 mg/kg, 3 mg/kg, 10 mg/kg and 30 mg/kg). In Group 5 participants will receive HepB mAb19 at the maximum tolerated dose (MTD). Participants will be followed for 48 weeks after HepB mAb19 or placebo infusion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05856890
Study type	Interventional
Source	Rockefeller University
Contact	Recruitment Specialist
Phone	800-782-2737
Email	rucares@rockefeller.edu
Status	Recruiting
Phase	Phase 1
Start date	August 7, 2023
Completion date	September 30, 2027

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