This First-In-Human (Phase I) study is a double blind, placebo controlled, single ascending dose trial performed in healthy adult male volunteers with Ir-CPI.
- ClinicalTrials.gov Trial Identifier NCT04653766
- Recruitment Status Active, not recruiting
- Primary Completion Date July 18, 2020
- The primary objectives of the study were to evaluate the safety and tolerability of Ir-CPI.
- Secondary study objectives included pharmacokinetic (PK) and pharmacodynamic (PD) assessment of Ir-CPI, i.e. the effect on prolongation of the aPTT coagulation parameter and on the inhibition of FXI and FXII activity.
- Thirty-two (32) healthy adult male volunteers were enrolled in this trial with a ratio 6-active and 2-placebo per dose level.
- A total of 4 dose levels of Ir-CPI ranging from 1.5 mg/kg up to 9 mg/kg were tested and administered intravenously for a 6-h period of infusion.
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.
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A Phase IIa is under preparation for Ir-CPI in patients with spontaneous intracerebral haemorrhage.