White Paper

Including Patients And Healthy Volunteers In First-In-Human Clinical Trials

The opportunities and limitations of “hybrid” clinical studies

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Phase I hybrid studies as described here are clinical trials that incorporate healthy volunteers as well as patients from the target indication in a single protocol. The insights gained from such hybrid studies can be extremely valuable, potentially delivering a deeper understanding of the safety, tolerability, and pharmacokinetics of a product, as well as a greater insight into the product’s pharmacodynamic effects and therapeutic potential — all at a very early stage of clinical development. Read our white paper to learn about the opportunities and limitations of hybrid studies in Phase I.


Chief Medical and Scientific Officer
Chief Scientific Officer, Early Phase Development

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