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Clinical Trial Summary

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Mortality is high and survivors frequently suffer from long-term sequelae. Extracellular histones have been identified as essential mediators in the pathogenesis of sepsis and septic shock. These toxic molecules are released by damaged cells in response to infection and high extracellular levels can induce tissue injury and multiple organ dysfunction syndrome. Extracellular histones can be neutralized by complexation with the new candidate drug called M6229, a non-anticoagulant heparin, allowing the use of elevated dose levels relative to regular unfractionated heparin. This project aims at the roll-out of a first-in-man clinical study in sepsis patients evaluating the safety, tolerability, pharmacokinetics and pharmacodynamic effects of intravenously administered M6229 in subjects suffering from sepsis.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT05208112
Study type Interventional
Source Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Contact Niels van Mourik, MD
Phone 020 566 9111
Email [email protected]
Status Recruiting
Phase Phase 1
Start date April 5, 2022
Completion date December 2022

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