Safety and pharmacokinetics of a human monoclonal antibody to rabies virus: A randomized, dose-escalation phase 1 study in adults

► Recently, a recombinant human IgG1 monoclonal antibody (SII RMab) was developed to replace serum-derived immunoglobulin. ► A randomized dose-escalation phase 1 study along with rabies vaccine was conducted in healthy adults. ► SII RMab was well tolerated with similar reactions to the licensed human rabies immunoglobulin (HRIG). ► The antibody titers in the 10 IU/kg cohort were comparable to the vaccine plus HRIG cohort. ► Future post-exposure prophylaxis studies are planned.