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