Phase I pain trials
Phase I mechanism based proof-of-concept experimental studies
The C4Pain strategy is to obtain drug efficacy data from human volunteers as early as possible in the drug development phase utilising human pain bio-markers and surrogate pain models to qualify go/no-go decisions as early as possible and to qualify the selection of the patient population (sub-population) which is most likely to respond to the compound.
Such studies can be done for single dose, multiple dosing or in dose escalation studies. Adding experimental pain measures in early studies are for free at they can be done in addition to pharmacokinetic sampling and side-effect profiling.
Phase I mechanism based proof-of-concept experimental clinical studies
The C4Pain strategy is to obtain drug efficacy data from patients as early as possible in the drug development phase utilising human pain bio-markers together with clinical measures to qualify go/no-go decisions as early as possible.
Such studies can be done for single dose, multiple dosing or in dose escalation studies. Adding experimental pain measures in early studies are for free at they can be done in addition to pharmacokinetic sampling and side-effect profiling.