Integrated FIH

Integrated First-in-Human (FIH) studies incorporate multiple objectives into a single SAD/MAD protocol, enabling our sponsors to achieve a greater level of insight into the clinical pharmacology of their investigational products (IP). Further, with capability for extemporaneous compounding of IP, we can add flexibility and speed to your clinical development program. This approach aligns with Pharmaron’s view on early phase drug development and our capabilities to perform these studies.

Integrated FIH Study Objectives:

  • Safety and tolerability
  • Food Effects (FE)
  • Clinical PK and bioanalysis
  • QT de-risking/thorough QT investigation
  • Adaptive designs including dose level and formulation development
  • Chinese/Japanese ethnobridging via intra-protocol PK comparison
  • PD assessments including analysis of biomarkers and clinical pathology
  • Early proof-of-concept with patients

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