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Considerations for First-In-Human Clinical Trials: Planning for Success

The First-in-human (FIH) clinical trial is a pivotal milestone in the drug development process and is the stage-gate before molecules can proceed to Phase II/proof of concept trials. Since 80% of drug candidates fail in Phase II or before, drug developers are increasingly looking at ways to increase the size of the data package collected in the FIH trial to improve their understanding of the drug candidate, mitigate development risks and shorten project timelines.

This webinar presents a set of case studies that illustrate: 

  • How to design and conduct complex multi-part adaptive FIH studies

- Benefits of a single integrated protocol and IRB considerations

- Strategies for starting doses, interim decisions and dose escalations

  • Real-time drug product manufacturing (GMP) and pharmacy compounding in early clinical studies

- Reduced timelines and API requirements

  • Maximising data output to robustly transition into Phase II patient trials

- Inclusion of biomarkers for proof of concept/mechanism

- Building the clinical pharmacology data package


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