HepB mAb19 in Individuals With Chronic Hepatitis B Infection

Part of paid clinical trials in New York, New York.

Sponsor
Rockefeller University
Study ID
NCT05856890
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • HepB mAb19 — BIOLOGICAL
    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
    Placebo will be normal sterile saline (NaCl 0.9%).

Study Details

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).

Key Dates

Start date
Aug 7, 2023
Status verified
Jan 2026
Primary completion
Dec 1, 2027
Completion
Mar 30, 2028

Study Design

Enrollment
37 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1a: HepB mAb19 1 mg/kg, IV
    Single intravenous infusion of HepB mAb19, dosed at 1 mg/kg.
  • Experimental: Group 2a: HepB mAb19 3 mg/kg, IV
    Single intravenous infusion of HepB mAb19, dosed at 3 mg/kg.
  • Experimental: Group 3a: HepB mAb19 10 mg/kg, IV
    Single intravenous infusion of HepB mAb19, dosed at 10 mg/kg.
  • Experimental: Group 4a: HepB mAb19 30 mg/kg, IV
    Single intravenous infusion of HepB mAb19, dosed at 30 mg/kg.
  • Experimental: Group 5: Maximum tolerated dose, IV
    Single intravenous infusion of HepB mAb19, dosed at the MTD
  • Placebo Comparator: Group 1b: Placebo 1 mg/kg, IV
    Single intravenous infusion of placebo - normal saline, dosed at 1 mg/kg.
  • Placebo Comparator: Group 2b: Placebo 3 mg/kg, IV
    Single intravenous infusion of placebo - normal saline, dosed at 3 mg/kg.
  • Placebo Comparator: Group 3b: Placebo 10 mg/kg, IV
    Single intravenous infusion of placebo - normal saline, dosed at 10 mg/kg.
  • Placebo Comparator: Group 4b: Placebo 30 mg/kg, IV
    Single intravenous infusion of placebo - normal saline, dosed at 30 mg/kg.

Primary Outcome Measure

Rate and severity of solicited adverse events that are Grade 2 or above within 2 weeks after administration. [ Time Frame: 2 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Ira Jacobson, MD
[email protected]
212-263-3095
The Rockefeller UniversityNew YorkNew York10065
Recruitment Specialist
[email protected]
800-782-2737
Marina Caskey, MD (PRINCIPAL_INVESTIGATOR)
Katrina Millard, NP (SUB_INVESTIGATOR)
Martina Turroja, MD (SUB_INVESTIGATOR)
Deanna Dong, NP (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By research site
NYU Langone Health· New York, NYThe Rockefeller University· New York, NY

Related Studies