Phase IIb Design

Case Study

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Phase IIb Design

Goal: Definition of doses and regimen to test in Phase IIb

Available data

  • Plasma concentration measurements in healthy volunteers (Phase I) and patients (Phase IIa)
  • Efficacy readout in patients (Phase IIa)
  • IV administration only in patients. SC in healthy volunteers.


  • Are the pharmacokinetics different in patients and healthy volunteers?
  • What is the SC bioavailability and the rate of absorption?
  • Which SC doses and regimen would be feasible in order to reach a minimum efficacious threshold at Cmin?
  • What is a reasonable concentration threshold for efficacy?


  • Integration of all available data
  • Dose/concentration/efficacy response characterization
  • Simulation based assessment of candidate dose scenarios is human

Benefit for Client’s Project

  • Better understanding of patient PK
  • More informed dose selection
  • Optimization of information generated in Phase IIb study (informing dose/concentration/response relationship)

R based PK/PD modeling workflow

We helped a client leverage the power of open-source modeling tools for internal modeling and simulation tasks

Reproducible Analyses

Computation without Borders and Reproducible Analyses: IQ Desktop

Animal to human PK translation

Informed FIH dose selection