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

PHASE1RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

August 26, 2024

Primary Completion Date

August 26, 2027

Study Completion Date

August 26, 2027

Conditions
Hepatitis B
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."

Trial Locations (1)

8200

RECRUITING

Department of Infectious Diseases, Aarhus University Hospital, Aarhus N

All Listed Sponsors
collaborator

Charite University, Berlin, Germany

OTHER

lead

Aarhus University Hospital

OTHER