In spring 2019, the first clinical (first-in-human) study of ROSgard was initiated. The early clinical development program consists of phase I studies (single and multiple doses) in healthy subjects, with the main purpose to evaluate the safety, tolerability and pharmacokinetic characteristics of ROSgard. A small phase Ib study in patients undergoing cardiac surgery will be performed in 2020.
The phase I study in healthy subjects is divided in two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD).
Based on favorable safety data in the ongoing SAD study, one additional and higher dose level will be tested in SAD before start of the MAD study. Regulatory approval to evaluate a higher dose level in SAD has already been obtained by the Swedish Medical Product Agency. A conditional approval to continue with the MAD study has also been obtained contingent lack of safety signals in the final SAD dose group. The company awaits approval by the Ethics Committe (application currently under evaluation) prior to initiation of the final dose group in SAD.
Following these studies, a smaller phase Ib study in patients undergoing cardiac surgery is planned during 2020.