Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:54 PM
Study NCT ID:
NCT07285603
Status:
COMPLETED
Last Update Posted:
2025-12-16
First Post:
2025-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study in Healthy Subjects to Assess the Safety and Tolerability of a 120-hour Continuous Infusion of M6229
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-09-29', 'studyFirstSubmitQcDate': '2025-12-12', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and type of Adverse Events (AEs)', 'timeFrame': 'Until End of Study (Day 14-18)', 'description': '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.'}, {'measure': 'Change in electrocardiograms (ECGs) from baseline', 'timeFrame': 'Until End of Study (Day 14-18)', 'description': 'Clinically significant changes in PR interval, QRS interval, QT interval, and QTcF'}, {'measure': 'Change in vital signs - blood pressure', 'timeFrame': 'Until End of Study (Day 14-18)', 'description': 'Changes in systolic and diastolic blood pressure in mmHg'}, {'measure': 'Change in vital signs - pulse rate', 'timeFrame': 'Until End of Study (Day 14-18)', 'description': 'Change in pulse rate measured in beat per minute'}, {'measure': 'Change in vital signs - respiratory rate', 'timeFrame': 'Until End of Study (Day 14-18)', 'description': 'Change in respiratory rate measured in breaths per minute'}, {'measure': 'Change in vital signs - body temperature', 'timeFrame': 'Until End of Study (Day 14-18)', 'description': 'Changes in body temperature measured in degrees Celcius'}, {'measure': 'Pharmacokinetics: Maximum observed analyte concentration (Cmax)', 'timeFrame': 'Until Day 9 (192 hours)'}, {'measure': 'Pharmacokinetics: Maximum observed analyte concentration (tmax)', 'timeFrame': 'Until Day 9 (192 hours)'}, {'measure': 'Pharmacokinetics: Last measured quantifiable concentration (tlast)', 'timeFrame': 'Until Day 9 (192 hours)'}, {'measure': 'Pharmacokinetics: Area under the curve (AUC)', 'timeFrame': 'Until Day 9 (192 hours)'}, {'measure': 'Pharmacokinetics: Elimination half-life (t1/2)', 'timeFrame': 'Until Day 9 (192 hours)'}, {'measure': 'Pharmacokinetics: Volume of distribution (Vd)', 'timeFrame': 'Until Day 9 (192 hours)'}, {'measure': 'Pharmacokinetics: Clearance (Cl)', 'timeFrame': 'Until Day 9 (192 hours)'}, {'measure': 'Pharmacokinetics: Amount excreted (Ae) in urine', 'timeFrame': 'Until Day 9 (192 hours)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['M6229', 'Unfractioned Heparin', 'Sepsis', 'Septic Shock'], 'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '10855969', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12360993', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://euclinicaltrials.eu/search-for-clinical-trials/?lang=en&EUCT=2024-512022-28-01', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of written informed consent\n* Male or female, aged 18 - 55 years at time of informed consent\n* BMI between 18.0 - 30.0 kg/m2\n* Normal vital signs (resting pulse rate and resting blood pressure)\n* Normal ECG parameters (PR, QRS, QTc)\n* Normal coagulation parameters (aPTT, PTT/INR and thrombin time)\n* Female subjects must have a negative serum pregnancy test\n* Willing and able to adhere to contraceptive requirements\n\nExclusion Criteria:\n\n* History of clinically significant medical illness\n* Laboratory abnormalities\n* Major surgery or trauma in previous 6 months\n* Positive test for HIV, HBsAg, or HCV\n* History of heart arrhythmias, tachycardia at rest, or history of risk factors for Torsade de Pointes syndrome\n* Clinically relevant allergy or drug hypersensitivity (incl. heparin)\n* Smokes daily more than 5 cigarettes or equivalent\n* History of postural disorders\n* Lack of adequate venous access\n* Current or ongoing history of urinary retention\n* Use of prescription or nonprescription medication within 7 days prior to Day 1\n* Received an investigational drug or medical device recently, or \\>3 investigational agents in last 12 months, or currently enrolled in an investigational study\n* Donated blood or substantial blood loss within 60 days prior to Day 1\n* Any condition, preplanned surgery or procedure that would interfere with the study conduct and/or with the subject's best interest\n* Subject is vulnerable\n* Subject is an employee of the investigator, clinical site, or Sponsor"}, 'identificationModule': {'nctId': 'NCT07285603', 'briefTitle': 'A Study in Healthy Subjects to Assess the Safety and Tolerability of a 120-hour Continuous Infusion of M6229', 'organization': {'class': 'INDUSTRY', 'fullName': 'Matisse Pharmaceuticals'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'M6229-C002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'M6229', 'description': 'A low-anticoagulant heparin in low, mid, and high dose. IV administration.', 'interventionNames': ['Drug: M6229']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline solution; IV administration', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'M6229', 'type': 'DRUG', 'description': 'Continuous 120-hour intravenous infusion of M6229', 'armGroupLabels': ['M6229']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Continuous 120-hour intravenous infusion of placebo (saline)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité Research', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Matisse Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}