1089. Use of a Whole-Body Quantitative System Pharmacology Physiologically-Based Pharmacokinetic (QSP/PBPK) Model to Support Dose Selection of ADG20: an Extended Half-Life Monoclonal Antibody Being Developed for the Prevention of Coronavirus Disease (COVID-19)

ABSTRACT: Abstract

Background

ADG20 is a fully human IgG1 monoclonal antibody engineered to have potent and broad neutralization against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and other SARS-like CoVs with pandemic potential as well as an extended-half-life. ADG20 is administered intramuscularly (IM). A QSP/PBPK model was constructed to support dose selection for a COVID-19 Phase 2/3 prevention trial (EVADE: NCT04859517).

Methods

A QSP/PBPK model and a CDC reference adult body weight distribution (45–150 kg) were used to simulate 1000 concentration-time profiles for candidate single-dose regimens of ADG20 (150–450 mg IM). As serum virus neutralizing antibody (sVNA) titers are reportedly a key correlate of protection from COVID-19, a regression equation between

SUBMITTER: Van Wart S 

PROVIDER: S-EPMC8644371 | biostudies-literature | 2021 Nov

REPOSITORIES: biostudies-literature