eligibility_summary
Inclusion: 18-70, chronic HBV ≥6 mo on stable NUC ≥6 mo, HBV DNA <LLOQ, anti-HBs-, HBeAg-. Pregnancy-capable: neg tests + dual contraception (1 highly effective). Can impregnate: condoms. Exclusion: advanced fibrosis, HCC risk (LI-RADS4/5 or AFP>20), HIV/HCV/HDV, transplant, CV/ECG disease, drug/biologic allergy, recent immunosuppression/infection/vaccination, liver/autoimmune disease, abnormal labs per protocol, pregnancy/lactation, prior anti-HBV mAb/HBIG, recent investigational drug.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: HepB mAb19, a human IgG1κ monoclonal antibody (IV) with FcRn-enhanced half-life. It binds the “a” determinant on HBV surface antigen (HBsAg, S-protein). Mechanisms: neutralizes HBV virions and subviral particles, forms immune complexes to accelerate antigen clearance, engages Fcγ receptor–mediated effector functions (ADCC, phagocytosis) via NK cells and myeloid cells, lowers circulating HBsAg to mitigate HBV-specific T-cell exhaustion and potentially restore adaptive responses. Targets: HBsAg on viral particles and HBsAg shed from infected hepatocytes, immune pathways including FcRn recycling, FcγR effector pathways, and HBV-specific T and B cell responses. Phase 1 single ascending dose (3, 10, 30 mg/kg) vs placebo, then open-label MTD cohort, outcomes include safety, PK, HBsAg/HBV DNA, and immune effects.