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Healthy SubjectsPhase 1NCT07285603

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

A Phase 1 study testing M6229 in people with Healthy Subjects, run by Matisse Pharmaceuticals at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
M6229
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
1 siteGermany
Study dates
21 Nov 2024to 18 Jun 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité Research

    Berlin

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Being tested
M6229, Placebo
Keywords
M6229, Unfractioned Heparin, Sepsis, Septic Shock
Medical subject headings
Sepsis, Shock, Septic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • M6229Drug

    Continuous 120-hour intravenous infusion of M6229

  • PlaceboDrug

    Continuous 120-hour intravenous infusion of placebo (saline)

Study groups in NCT07285603
Study groupRoleWhat they receive
M6229ExperimentalA low-anticoagulant heparin in low, mid, and high dose. IV administration.
Receives: Drug: M6229
PlaceboPlacebo comparatorSaline solution; IV administration
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Until End of Study (Day 14-18)

  2. Change in electrocardiograms (ECGs) from baseline

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

    Measured: Until End of Study (Day 14-18)

  3. Change in vital signs - blood pressure

    Changes in systolic and diastolic blood pressure in mmHg

    Measured: Until End of Study (Day 14-18)

  4. Change in vital signs - pulse rate

    Change in pulse rate measured in beat per minute

    Measured: Until End of Study (Day 14-18)

  5. Change in vital signs - respiratory rate

    Change in respiratory rate measured in breaths per minute

    Measured: Until End of Study (Day 14-18)

  6. Change in vital signs - body temperature

    Changes in body temperature measured in degrees Celcius

    Measured: Until End of Study (Day 14-18)

  7. Pharmacokinetics: Maximum observed analyte concentration (Cmax)

    Measured: Until Day 9 (192 hours)

  8. Pharmacokinetics: Maximum observed analyte concentration (tmax)

    Measured: Until Day 9 (192 hours)

  9. Pharmacokinetics: Last measured quantifiable concentration (tlast)

    Measured: Until Day 9 (192 hours)

  10. Pharmacokinetics: Area under the curve (AUC)

    Measured: Until Day 9 (192 hours)

  11. Pharmacokinetics: Elimination half-life (t1/2)

    Measured: Until Day 9 (192 hours)

  12. Pharmacokinetics: Volume of distribution (Vd)

    Measured: Until Day 9 (192 hours)

  13. Pharmacokinetics: Clearance (Cl)

    Measured: Until Day 9 (192 hours)

  14. Pharmacokinetics: Amount excreted (Ae) in urine

    Measured: Until Day 9 (192 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start21 Nov 2024
  3. Primary completion18 Jun 2025
  4. Study completion18 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07285603
Sponsor's protocol ID
M6229-C002
Status last verified
Dec 2025
First submitted
29 Sep 2025
Last updated
16 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38338654

  • 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.

    PubMed 40824474

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing M6229 in people with Healthy Subjects, run by Matisse Pharmaceuticals at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and type of Adverse Events (AEs) (time frame: Until End of Study (Day 14-18)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07285603, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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