Proof-of-Concept Phase I/II Trials

Arguably, PoC trials are the most challenging to design due very limited knowledge and the highest of business expectations. Due to limited or no prior human exposure, the primary objective of these trials must be safety, yet - at a very limited sample size - they need to provide sufficient evidence/hint of potential efficacy for business considerations.

SCiAN has extensive track record in PoC trials in:

  • Autoimmune - Inflammatory
  • Cardiovascular
  • CNS - Neurology - Pain
  • Dermatology
  • Diabetes - Metabolic
  • Gastroenterology
  • Infectious diseases
  • Respiratory.

A recent publication illustrates well what can be achieved with our help in PoC trials: A first-in-human study of PDC31.

Databases by Study Design1

  • Dose-escalation: open-label, single-arm
  • Dose-escalation: randomized, placebo-controlled (blinded) design
  • Parallel group randomized (blinded) dose ranging w/out placebo group
  • Dose-escalation CRM design - original
  • 2-stage / multi-stage designs 
  • Open label and other parallel group designs
  • Adaptive designs.

1) PK, PD and biomarker sub-studies supported