HepB mAb19 in Individuals With Chronic Hepatitis B Infection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRockefeller University
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).
Eligibility criteria
Qualifiers
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;
HBV DNA below lower limit of quantification;
Disqualifiers
Presence of a LI-RADS4 or 5 liver lesion on imaging within 12 months from entry or done at pre-infusion visit, if prior results not available.
Alpha fetoprotein > 20 ng/ml Note: AFP above normal but < 20 is acceptable for entry if earlier AFP levels (older than 6 months) are within normal range and imaging is negative in last 3 months).
HIV-1, HCV or hepatitis delta virus infection within 12 months from entry or done at screen, if prior results not available.
History of hematopoietic stem cell transplant or solid organ transplant;
Trial design
Treatments tested in this trial
- HepB mAb19
- Sterile Saline
Treatment groups
37 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Rockefeller University
Lead sponsor
NYU Langone Health
Collaborator
Source ClinicalTrials.gov