Recruiting

SAMBAMonoclonal Antibody for Chronic Hepatitis B

What is being tested

HepB mAb19

Drug

Who is being recruted

Blood-Borne Infections+14

+ Chronic Disease

+ Communicable Diseases

From 18 to 70 Years

+43 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: August 2024

See protocol details

Summary

Principal SponsorAarhus University Hospital

Study ContactOle Schmeltz Søgaard, MD, ProfessorMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 26, 2024

Actual date on which the first participant was enrolled.

This study focuses on evaluating a new treatment for individuals with chronic Hepatitis B infection, using a specially designed antibody called HepB mAb19. Chronic Hepatitis B is a long-lasting infection that can lead to liver damage and other health issues. The study aims to test the safety and effectiveness of this antibody, which targets a protein on the virus, potentially helping the body's immune system fight the infection. Researchers hope that this treatment can reduce the virus levels in the body and improve the immune response, providing a new option for managing the disease effectively. Participants in the study receive the antibody HepB mAb19 through an intravenous infusion, meaning it is delivered directly into the bloodstream. The study is conducted in two parts. In the first part, different doses of the antibody are tested to find the safest and most effective amount. In the second part, the best dose is used to treat a larger group of participants. Blood samples are collected at various times to monitor the safety of the treatment and its effects on the virus and the immune system. Regular follow-up checks are conducted over several weeks to ensure the treatment's effectiveness and safety. The study aims to understand how the antibody is processed in the body and its impact on the infection.

Official TitleSafety and Antiviral Activity of a Monoclonal Hepatitis B Antibody: a First-in-human Phase 1, Placebo-controlled, Single Dose Escalation Clinical Trial in Individuals with Chronic Hepatitis B Infection (The SAMBA Study)

NCT06668727

Principal SponsorAarhus University Hospital

Study ContactOle Schmeltz Søgaard, MD, ProfessorMore contacts

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

30 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsHepatitisHepatitis BHepatitis, ChronicHepatitis, Viral, HumanInfectionsLiver DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVirus DiseasesHepadnaviridae InfectionsHepatitis B, ChronicDisease Attributes

Criteria

18 inclusion criteria required to participate

Percutaneous contraceptive patches;

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;

Show More Criteria

25 exclusion criteria prevent from participating

Clinical symptoms, imaging studies or liver histology suggestive of advanced fibrosis (exclude fibrosis grade 3 and 4 by FibroScan) (Fibroscan®< 9 kpa) 12 months prior to entry or done at the pre-infusion visit. Note: If FibroScan results are not available, imaging will be performed at the preinfusion visit.

Presence of a LI-RADS4 or 5 liver lesion on imaging 12 months prior to entry or done at pre-infusion visit, if prior results not available.

Alpha fetoprotein >20 ng/ml. Note: Alpha-fetoprotein (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 12 months prior to entry or done at screen, if prior results not available;

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Participants (n=4), will be enrolled in Group 1 (HepB mAb19 3 mg/kg or placebo, single dose) and randomized 3:1 to HepB mAb19 or placebo with each participant being dosed at least 72 hours apart. Following enrollment and administration of study drug in the first two participants, the Protocol Safety Review Team (PSRT) will review available safety data (including safety labs) and only following this review and in the absence of dose limiting toxicities (DLT), the remaining two participants in Group 1 will be enrolled and randomized to HepB mAb19 or placebo.

Group II

Experimental

Participants (n=4), will be enrolled in Group 2 (HepB mAb19 10 mg/kg or placebo, single dose) and randomized 3:1 to HepB mAb19 or placebo with each participant being dosed at least 72 hours apart.

Group III

Experimental

Participants (n=4), will be enrolled in Group 2 (HepB mAb19 30 mg/kg or placebo, single dose) and randomized 3:1 to HepB mAb19 or placebo with each participant being dosed at least 72 hours apart.

Group IV

Experimental

Participants (n=18) will enroll in Group 4 in an open-label fashion and will receive the MTD. Enrollment in Group 4 will begin after all 4 participants enrolled in the preceding dose group reach at least 28 days, none of the dose escalating halting criteria outlined above occur, and following review of available safety data by the PSRT

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Department of Infectious Diseases, Aarhus University Hospital

Aarhus N, DenmarkOpen Department of Infectious Diseases, Aarhus University Hospital in Google Maps

Recruiting

One Study Center