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

A Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of M6229 Administered as a 120-hour Continuous Infusion at Three Sequential Dose Levels Versus Placebo in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: M6229; Drug: Placebo

Detailed Description

Three dose levels of M6229 will be assessed in sequential study cohorts. Each cohort will consist of up to 3 male and 3 female subjects (2 male and 2 female subjects on M6229, 1 male and 1 female subject on placebo). Following a screening period of up to 28 days during which eligibility will be assessed, subjects will be randomized to M6229 or placebo and start a 120-hour continuous infusion on Day 1. Subjects will undergo safety assessments (incl. laboratory assessments) and pharmacokinetic sampling following a predefined schedule from Day 1 until Day 9. Subjects will be discharged on Day 9. The clinical study will be completed with an end-of-study visit, which will take place between 5 to 9 days after the last treatment-defined assessment.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charité Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Subject is an employee of the investigator, clinical site, or Sponsor

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M6229; A low-anticoagulant heparin in low, mid, and high dose. IV administration.	Drug: M6229; Continuous 120-hour intravenous infusion of M6229
Placebo Comparator: Placebo; Saline solution; IV administration	Drug: Placebo; Continuous 120-hour intravenous infusion of placebo (saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Matisse Pharmaceuticals

Publications and helpful links

General Publications

• Iten PX, Meier M. Beta-hydroxybutyric acid--an indicator for an alcoholic ketoacidosis as cause of death in deceased alcohol abusers. J Forensic Sci. 2000 May;45(3):624-32.
• Zimmer KP, Lentze MJ, Nutzenadel W, Rodeck B. On the situation of pediatric gastroenterology in a so-called developed country. J Pediatr Gastroenterol Nutr. 2002 Sep;35(3):241-2. doi: 10.1097/00005176-200209000-00001. No abstract available.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2024
• Primary Completion (Actual): June 18, 2025
• Study Completion (Actual): June 18, 2025

Study Registration Dates

• First Submitted: September 29, 2025
• First Submitted That Met QC Criteria: December 12, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Septic Shock; Sepsis; M6229; Unfractioned Heparin
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Sepsis; Shock, Septic
• Other Study ID Numbers: M6229-C002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No