Emerging Trends for FIH Studies Over the Last 4 Years

Quotient Sciences has conducted over 80 first in human (FIH) studies from Jan 2020 to Dec 2024, with approximately 50 % being conventional FiH and 50 % using Translational Pharmaceutics, a platform that allows formulation development, drug product clinical manufacturing using small batches (200-300 units) with limited stability (regulatory filing with 7 days) and rapid dosing in the clinic. This platform allows formulations optimization (e.g. testing different formulation technologies) or changes to the formulation during FiH based on emerging clinical data. Retrospective analysis assesses the number of FIH studies that were conventional, included PD endpoints, Holter monitoring or used Quotient Translational Pharmaceutics model to integrate drug product manufacturing with clinical testing and include the option for formulation optimization. The analysis also highlights the risk of using preclinical data to predict clinical formulation performance and provides case studies where preclinical PK predictions were much lower than observed in the clinic.