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Summary of the Clinical Data
Ir-CPI was well tolerated with no dose-limiting toxicities; there were no safety issues, no related serious adverse events nor adverse events of specific interest, i.e. adverse events related to bleeding.
Plasma exposure during infusion (AUC0-6h) and mean peak plasma concentrations increased dose-proportionally. PK profile of escalating single IV infusion doses of Ir-CPI in healthy male participants was characterized by maximum mean plasma concentrations observed at the end of infusion (i.e. 6 hours). Exposure-dependent changes were observed in the PD parameters: prolongation of the aPTT and inhibition of FXI and FXII procoagulant activities. There was a correlation between Ir-CPI plasma concentrations and biological activity.
For more information, please read the Press Release here
See also our ongoing Phase IIa trial with Ir-CPI in patients suffering from spontaneous intracerebral haemorrhage.