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Safety and Antiviral Activity of a Monoclonal Hepatitis B Antibody (The SAMBA Study)

NCT06668727 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-10-31

No results posted yet for this study

Summary

Hepatitis B virus (HBV) remains a major global health problem with an estimated 257 million people living with the infection worldwide. Chronic HBV (CHB) is a major cause of liver cirrhosis and hepatocellular carcinoma. While antiviral therapies are available and suppress viral levels, treatment is long-term, does not clear the infection and rarely leads to long-term control once discontinued. Moreover, treatment access is not ideal on a global level with less than 10% of people in need receiving treatment. Although a strategy that eliminates all viral particles from the body represents the "holy grail" of HBV therapy, a strategy that leads to HBsAg loss and allows patients to stop treatment is highly desirable. New strategies to achieve either complete viral clearance or a state of viral control without the need for long-term treatment are being developed, including approaches to restore immune responses. Antibodies are key modulators of immune responses because of their dual functionality. In addition to directly targeting a viral antigen, antibodies differ from direct antivirals in that they can recruit other immune cells to eliminate infected cells and accelerate viral clearance.

This study will evaluate the safety and pharmacokinetics of a monoclonal antibody that was isolated from an HBV-vaccinated individual, HepB mAb19, as well as its potential effects on viral levels and antiviral immune responses in individuals living with CHB.

Conditions

Interventions

DRUG

HepB mAb19

The study has two parts: Part A will involve administering a single ascending dose of HepB mAb19 or placebo using a randomized, double-blind method in Groups 1-3 at dose levels of 3, 10, and 30 mg/kg. Participants enrolled in Groups 1-3 will be randomized at a 3:1 ratio to receive HepB mAb19 or placebo. Part B will assess the maximum tolerated dose (MTD) in Group 4 in an openlabel fashion. Participants will receive HepB mAb19 at MTD.

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Ole S. Søgaard, MD, Professor · Infectious Diseases, Aarhus University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-26
Primary Completion
2027-08-26
Completion
2027-08-26

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06668727 on ClinicalTrials.gov