The Phase I clinical trial at Liverpool is designed to test the safety of APPA. The first stage is now complete, and the clinical trial dose escalation committee has approved the transition from a single dose in healthy volunteers to multiple ascending 2 week dosing in osteoarthritis patients.
In this part of a clinical trial, dose levels and frequency are chosen to achieve therapeutic drug levels and are maintained at steady state for 2 weeks to allow appropriate safety parameters to be monitored. In this instance osteoarthritis patients will be studied at three different dose levels, at and above the expected therapeutic dose level, to determine the ‘safety margin’ for repeat dose administration. Osteoarthritis biomarkers and patient questionnaires will also be used to make an early assessment of APPA’s clinical effect but this will likely be limited given the relatively short dosing duration.