Clinical Data
In the Phase 1 study, XEN801 was found to be safe and generally well tolerated. In total, 48 healthy volunteers were dosed for either a 14-day or 21-day treatment period. A number of different dose volumes of the 1% XEN801 drug product were evaluated in the Phase 1 clinical trial with dosing on the back and face of healthy volunteers to determine the maximum tolerated dose. As expected, the most common side effects were localized, generally mild skin reactions. No serious adverse events were observed. Maximal plasma concentrations of XEN801 were low, whereas the median skin concentration of XEN801 was above the drug concentration predicted for efficacy for all dose volumes evaluated. A Phase 2 dose was selected based on favorable tolerability and skin drug concentrations.