Integrated FIH

Integrated First-in-Human (FIH) studies incorporate multiple objectives into a single phase I protocol, enabling our sponsors to achieve a greater level of insight into the clinical pharmacology of their test article.

Scientific objectives addressed in FIH studies:

  • Complex drug delivery
  • On-site, non-sterile or sterile compounding
  • Adaptive designing including dose level and formulation development
  • QT de-risking/thorough QT investigation
  • Intra-protocol comparison of PK between Japanese and non-Japanese volunteers
  • PD assessments including analysis of biomarkers and clinical pathology
  • Patient recruitment for early proof-of-concept

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