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

The opportunities and limitations of “hybrid” clinical studies


Michael Murphy, MD, PhD | Sherilyn Adcock, RPh, PhD

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.

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Michael Murphy, MD, PhD
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Michael Murphy, MD, PhD

Chief Medical and Scientific Officer
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Sherilyn Adcock, RPh, PhD
MEET THE AUTHOR

Sherilyn Adcock, RPh, PhD

Chief Scientific Officer, Early Phase Development
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