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First-in-human (FIH) studies are not a homogenous type. The U.S. FDA phase I trial, includes the initial human exposure to an investigational drug (IND). Phase I trials are relatively small, typically having 20-80 subjects, and they afford researchers a baseline of pharmacovigilance data. These studies can also give an early indication of an compound’s mechanisms of action in humans.
Deviations from this norm include having participants in phase I drug tests receive a completely novel agent, an agent belonging to a class of drugs already studied in humans, a combination of new and approved drugs, a new combination of approved drugs, or a new dose of an approved drug. Another type of phase I trial involves the first exposure of a specific population, such as elderly people, to an already approved drug. The classic phase I trial design is often modified in studies evaluating the initial human response to gene transfer and other biological agents.
PSNResearch has devoted considerable time and resources to the development of a proprietary process model specifically tailored to FIH studies. Contact one of our scientists for more information on our process, our extensive global network of investigative sites, and our complete toolset for early clinical development.
PSNResearch – your complete and comprehensive solution for FIH clinical development: