In spring 2019, the first clinical study of ROSgard was initiated. The early clinical development programme consists of a phase I study on healthy subjects, with the main purpose of determining ROSgard's safety profile and pharmacokinetic characteristics, and a smaller phase Ib study on patients undergoing open-heart surgery.
The phase I study on healthy subjects is divided in two parts. Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD). The results from the ongoing part 1 (SAD) are expected to be announced approximately 6 months after the first dose exposure. The results from part 2 (MAD) are expected to be announced approximately 3 months after the study initiation date. As soon as the ongoing phase I study is completed (SAD and MAD), a smaller phase Ib study on patients undergoing open-heart surgery is planned to commence. It is expected to be initiated in 2020, and the results are expected to be available within a further six months.
A phase II study aiming to demonstrate clinical efficacy of ROSgard in patients is envisaged thereafter. The planning of this study is in progress, and the study can hopefully be initiated in late 2020.