Health TrialsbyHealthPanel

HepB mAb19 in Individuals With Chronic Hepatitis B Infection

ConditionsHepatitis b VirusHepatitis B
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • HepB mAb19

    Biological/Vaccine

    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).

  • Sterile Saline

    Other intervention

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

Treatment groups

37 Participants
are divided into 9 treatment groups

9

Treatment groups

See each treatment group below.

Group A: Group 1a: HepB mAb19 1 mg/kg, IVExperimental treatment 1 intervention
Group B: Group 2a: HepB mAb19 3 mg/kg, IVExperimental treatment 1 intervention
Group C: Group 3a: HepB mAb19 10 mg/kg, IVExperimental treatment 1 intervention
Group D: Group 4a: HepB mAb19 30 mg/kg, IVExperimental treatment 1 intervention
Group E: Group 5: Maximum tolerated dose, IVExperimental treatment 1 intervention
Group F: Group 1b: Placebo 1 mg/kg, IVPlacebo comparator 1 intervention
Group G: Group 2b: Placebo 3 mg/kg, IVPlacebo comparator 1 intervention
Group H: Group 3b: Placebo 10 mg/kg, IVPlacebo comparator 1 intervention
Group I: Group 4b: Placebo 30 mg/kg, IVPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate and severity of solicited adverse events that are Grade 2 or above within 2 weeks after administration.

The occurrence of solicited AEs will be assessed 2 weeks after IP administration.

Time frame
2 weeks
2

Rate and severity of treatment-emerging unsolicited adverse events that are Grade 2 or above (including confirmed laboratory abnormalities) within 2, 12, 24 and 48 weeks after administration.

The occurrence of treatment-emerging AEs will be assessed after IP administration

Time frame
48 weeks
3

Rate and severity of participants with serious adverse events (SAEs) throughout the study period that are considered related to investigational product and the duration of those SAEs.

The occurrence of SAEs will be assessed after IP administration

Time frame
48 weeks
4

Rate and severity of participants with potential immune complex disease (ICD) throughout the study period following investigational product (IP) administration.

The occurrence of immune complex disease will be assessed after IP administration

Time frame
48 weeks

Secondary outcomes

1

Rate and severity of treatment-related adverse events during study follow up.

The occurrence of treatment-related AEs will be assessed after IP administration.

Time frame
48 weeks
2

Rate of induced anti-HepB mAb19 antibodies in all study groups.

Occurrence of anti-HepB mAb19 antibodies will be assessed at baseline and after IP administration.

Time frame
48 weeks
3

Change in quantitative HBsAg levels from baseline (day 0) at each scheduled follow up visit.

Serum HBsAg levels will be measured from baseline (day 0) until end of study follow up.

Time frame
48 weeks
4

Detection of HBsAg by a qualitative assay at each scheduled follow up visit.

Qualitative measure of HBsAg will be performed from baseline (day 0) until end of study follow up.

Time frame
48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rockefeller University

Lead sponsor

NYU Langone Health

Collaborator

Source ClinicalTrials.gov
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