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Intravenously Administered M6229 in Critically Ill Sepsis Patients

NCT05208112 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-02-11

No results posted yet for this study

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.

Conditions

  • Sepsis
  • Septic Shock
  • Critical Illness

Interventions

DRUG

M6229

Continuous intravenous infusion of M6229, a low-anticoagulant fraction of heparin. Dose-escalation is based on a modified continual reassessment method (mCRM) including escalation with overdose control (EWOC).

Sponsors & Collaborators

  • Matisse Pharmaceuticals

    collaborator INDUSTRY

  • Maastricht University

    collaborator OTHER

  • Maastricht University Medical Center

    collaborator OTHER

  • A.P.J. Vlaar

    lead OTHER

Principal Investigators

  • Alexander P Vlaar, MD, PhD, MBA · Department of Intensive Care Medicine, Amsterdam UMC, location AMC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-05
Primary Completion
2023-09-28
Completion
2023-09-28

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05208112 on ClinicalTrials.gov