The situation
First-in-human is complete. The single and multiple ascending dose data are in, and the Phase 2 dose now has to be chosen and justified.
What we do
- Characterise the PK profile across the dose range
- Find the sources of variability that actually matter
- Simulate candidate doses against the exposure target
What you get
- A population PK model, covariates documented
- The recommended Phase 2 dose, with the simulations behind it
- A Phase 2 sampling plan that keeps the model learning
Regulatory basis
FDA's population PK guidance describes using population analyses to identify the factors that explain variability in exposure and to inform dosing. Applied to the first-in-human data, it gives the Phase 2 dose a quantitative basis rather than resting on tolerability alone.