Intravenously Administered M6229 in Critically Ill Sepsis Patients
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
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.