Rajbharan Yadav, Siddharth Sukumaran, Jeff Lutman, Mayur S Mitra, Wendy Halpern, Tianhe Sun, A Francesca Setiadi, Margaret Neighbors, X Rebecca Sheng, Victor Yip, Ben-Quan Shen, Chang Liu, Lyrialle Han, Ayse Meric Ovacik, Yan Wu, Sara Glickstein, Rebecca Kunder, Joseph R Arron, Lin Pan, Amrita V Kamath, Eric G Stefanich
MTBT1466A is a high-affinity TGFβ3-specific humanized IgG1 monoclonal antibody with reduced Fc effector function, currently under investigation in clinical trials as a potential anti-fibrotic therapy. Here, we characterized the pharmacokinetics (PK) and pharmacodynamics (PD) of MTBT1466A in mice and monkeys and predicted the PK/PD of MTBT1466A in humans to guide the selection of the first-in-human (FIH) starting dose. MTBT1466A demonstrated a typical IgG1-like biphasic PK profile in monkeys, and the predicted human clearance of 2...
July 8, 2023: Journal of Pharmaceutical Sciences