Semi-mechanistic population pharmacokinetic modeling of DZIF-10c, a neutralizing antibody against SARS-Cov-2: predicting systemic and lung exposure following inhaled and intravenous administration

DZIF-10c (BI 767551) is a SARS-CoV-2-neutralizing recombinant monoclonal antibody designed for both systemic and respiratory tract exposure via intravenous infusion and inhalation. A semi-mechanistic population pharmacokinetic model integrated preclinical and clinical data using allometric scaling to characterize lung and systemic exposure profiles. Simulations showed that inhalation offers effective lung exposure at lower doses, while combining inhalation with intravenous therapy achieves sustained levels in both lungs and systemic circulation, optimizing treatment outcomes.