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

NCT07285603 | Completed Phase 1

• 1 other identifier: M6229-C002
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Keywords

M6229; Unfractioned Heparin; Sepsis; Septic Shock

Outcome Measures

Primary Outcomes (14)

• Incidence and type of Adverse Events (AEs)

  Any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

  Until End of Study (Day 14-18)

• Change in electrocardiograms (ECGs) from baseline

  Clinically significant changes in PR interval, QRS interval, QT interval, and QTcF

  Until End of Study (Day 14-18)

• Change in vital signs - blood pressure

  Changes in systolic and diastolic blood pressure in mmHg

  Until End of Study (Day 14-18)

• Change in vital signs - pulse rate

  Change in pulse rate measured in beat per minute

  Until End of Study (Day 14-18)

• Change in vital signs - respiratory rate

  Change in respiratory rate measured in breaths per minute

  Until End of Study (Day 14-18)

• Change in vital signs - body temperature

  Changes in body temperature measured in degrees Celcius

  Until End of Study (Day 14-18)

• Pharmacokinetics: Maximum observed analyte concentration (Cmax)

  Until Day 9 (192 hours)

• Pharmacokinetics: Maximum observed analyte concentration (tmax)

  Until Day 9 (192 hours)

• Pharmacokinetics: Last measured quantifiable concentration (tlast)

  Until Day 9 (192 hours)

• Pharmacokinetics: Area under the curve (AUC)

  Until Day 9 (192 hours)

• Pharmacokinetics: Elimination half-life (t1/2)

  Until Day 9 (192 hours)

• Pharmacokinetics: Volume of distribution (Vd)

  Until Day 9 (192 hours)

• Pharmacokinetics: Clearance (Cl)

  Until Day 9 (192 hours)

• Pharmacokinetics: Amount excreted (Ae) in urine

  Until Day 9 (192 hours)

Study Arms (2)

M6229

EXPERIMENTAL

A low-anticoagulant heparin in low, mid, and high dose. IV administration.

Drug: M6229

Placebo

PLACEBO COMPARATOR

Saline solution; IV administration

Drug: Placebo

Interventions

M6229 DRUG

Continuous 120-hour intravenous infusion of M6229

M6229

Placebo DRUG

Continuous 120-hour intravenous infusion of placebo (saline)

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of written informed consent
• Male or female, aged 18 - 55 years at time of informed consent
• BMI between 18.0 - 30.0 kg/m2
• Normal vital signs (resting pulse rate and resting blood pressure)
• Normal ECG parameters (PR, QRS, QTc)
• Normal coagulation parameters (aPTT, PTT/INR and thrombin time)
• Female subjects must have a negative serum pregnancy test
• Willing and able to adhere to contraceptive requirements

You may not qualify if:

• History of clinically significant medical illness
• Laboratory abnormalities
• Major surgery or trauma in previous 6 months
• Positive test for HIV, HBsAg, or HCV
• History of heart arrhythmias, tachycardia at rest, or history of risk factors for Torsade de Pointes syndrome
• Clinically relevant allergy or drug hypersensitivity (incl. heparin)
• Smokes daily more than 5 cigarettes or equivalent
• History of postural disorders
• Lack of adequate venous access
• Current or ongoing history of urinary retention
• Use of prescription or nonprescription medication within 7 days prior to Day 1
• Received an investigational drug or medical device recently, or \>3 investigational agents in last 12 months, or currently enrolled in an investigational study
• Donated blood or substantial blood loss within 60 days prior to Day 1
• Any condition, preplanned surgery or procedure that would interfere with the study conduct and/or with the subject's best interest
• Subject is vulnerable

Sponsors & Collaborators

• Matisse Pharmaceuticals: lead

Study Sites (1)

Charité Research

Berlin, Germany

Location

Related Publications (2)

• 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.

  PMID: 38338654 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.

  PMID: 40824474 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Sepsis; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: December 16, 2025
• Study Start: November 21, 2024
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)