HepB mAb19 in Individuals With Chronic Hepatitis B Infection

Recruiting Phase 1 Interventional Study
Hepatitis b Virus Hepatitis B
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
37 (estimated)
Sponsor
Rockefeller University · Other
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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age 18 to 70; * HBV infection confirmed by positive HBsAg for \>/= 6 months; * On HBV-active nucleos(t)ide therapy for \>/= 6 months without change in NRTI in the previous 3 months; * The following laboratory values within 49 days from study entry (day 0): * HBV DNA below lowe…
Contacts

Recruitment Specialist

800-782-2737

rucares@rockefeller.edu

CONTACT

Marina Caskey, MD

212-327-7396

mcaskey@rockefeller.edu

CONTACT