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Completed

NCT Number: NCT07285603

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

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.

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Key information

Conditions

Healthy Subjects Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charité Research

Berlin, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

M6229

Drug

Continuous 120-hour intravenous infusion of M6229

Placebo

Drug

Continuous 120-hour intravenous infusion of placebo (saline)

Primary outcomes

  1. Incidence and type of Adverse Events (AEs)

    Time frame: Until End of Study (Day 14-18)

    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.

  2. Change in electrocardiograms (ECGs) from baseline

    Time frame: Until End of Study (Day 14-18)

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

  3. Change in vital signs - blood pressure

    Time frame: Until End of Study (Day 14-18)

    Changes in systolic and diastolic blood pressure in mmHg

  4. Change in vital signs - pulse rate

    Time frame: Until End of Study (Day 14-18)

    Change in pulse rate measured in beat per minute

  5. Change in vital signs - respiratory rate

    Time frame: Until End of Study (Day 14-18)

    Change in respiratory rate measured in breaths per minute

  6. Change in vital signs - body temperature

    Time frame: Until End of Study (Day 14-18)

    Changes in body temperature measured in degrees Celcius

  7. Pharmacokinetics: Maximum observed analyte concentration (Cmax)

    Time frame: Until Day 9 (192 hours)

  8. Pharmacokinetics: Maximum observed analyte concentration (tmax)

    Time frame: Until Day 9 (192 hours)

  9. Pharmacokinetics: Last measured quantifiable concentration (tlast)

    Time frame: Until Day 9 (192 hours)

  10. Pharmacokinetics: Area under the curve (AUC)

    Time frame: Until Day 9 (192 hours)

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

    Time frame: Until Day 9 (192 hours)

  12. Pharmacokinetics: Volume of distribution (Vd)

    Time frame: Until Day 9 (192 hours)

  13. Pharmacokinetics: Clearance (Cl)

    Time frame: Until Day 9 (192 hours)

  14. Pharmacokinetics: Amount excreted (Ae) in urine

    Time frame: Until Day 9 (192 hours)

Sponsors and collaborators

Lead sponsor

Matisse Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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