A Study in Healthy Subjects to Assess the Safety and Tolerability of a 120-hour Continuous Infusion of M6229

Summary

This is a Phase I, single-center, randomized, single-blind, placebo-controlled study in healthy subjects assessing the safety, tolerability and pharmacokinetic profile of three different dose levels of M6229 when administered continuously for 120 hours.

Timeline

Start

2024-11-21

Primary completion

2025-06-18

Completion

2025-06-18

Publications

• Background Reutelingsperger CPM, Gijbels MJ, Spronk H, Van Oerle R, Schrijver R, Ekhart P, de Kimpe S, Nicolaes GAF. M6229 Protects against Extracellular-Histone-Induced Liver Injury, Kidney Dysfunction, and Mortality in a Rat Model of Acute Hyperinflammation. Int J Mol Sci. 2024 Jan 23;25(3):1376. doi: 10.3390/ijms25031376.
• Background van Mourik N, van Amstel RBE, Slim MA, van Vught LA, van der Poll T, Huckriede J, de Vries F, de Kimpe SJ, Crabbe R, van Leeuwen SJM, Ekhart PF, Reutelingsperger CPM, Nicolaes GAF, Vlaar APJ, Muller MCA. A phase I trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenously administered low-anticoagulant heparin (M6229) in critically ill sepsis patients. Intensive Care Med Exp. 2025 Aug 18;13(1):84. doi: 10.1186/s40635-025-00790-4.

Drugs

Indications

No indication recorded.