Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-30 @ 5:44 AM
Study NCT ID:
NCT06324604
Status:
RECRUITING
Last Update Posted:
2025-02-06
First Post:
2024-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Part A will enroll Healthy Adult Volunteers will be randomized, double-blind, placebo-controlled, single ascending dose (SAD), randomized to MTX-101 or placebo in a 1:1 ratio for the first 2 participants (sentinel dosing) and a 3:1 ratio thereafter. Participants in the multiple ascending dose (MAD) will be randomized in a 3:1 ratio and be dosed on Days 1 and 22.\n\nPart B of this study plans to enroll at least 24 (up to 44) participants with CeD or T1D, randomized in a 1:1 ratio, in 2 sequential cohorts. Approximately 12 CeD and 12 T1D patients will be enrolled in Part B, with the option to enroll up to a maximum of 44 total (CeD and/or T1D patients). Participants in Cohort B8 will be dosed with MTX-101 on Days 1 \\& 29, then placebo on Day 57 or placebo on Day 1 and MTX-101 on days 29 \\& 57. Participants in Cohort B9 will be dosed with MTX-101 or placebo on Day 1 and MTX-101 on Day 29. Patients will be followed for 6 months after the first dose.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2024-02-27', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'pharmacodynamics (PD) of MTX-101', 'timeFrame': 'Enrollment up to 11 weeks following the last dose', 'description': 'Evaluate how MTX-101 affect the immune system by the measuring the activity, presence and amount of signaling proteins and cells that help control inflammation.'}, {'measure': 'Receptor occupancy of MTX-101', 'timeFrame': 'Enrollment up to 11 weeks following the last dose', 'description': 'To examine the binding ability of MTX-101 to targets on the cell surface.'}], 'primaryOutcomes': [{'measure': 'Safety of single, ascending dose levels of MTX-101', 'timeFrame': 'Enrollment to 8 weeks post dose', 'description': 'Assess the safety of single, ascending dose levels of MTX-101 by evaluating the incidence, severity, and seriousness of treatment-emergent adverse events'}, {'measure': 'Safety of multiple, ascending dose levels of MTX-101', 'timeFrame': 'Enrollment to 11 weeks following the last dose', 'description': 'Assess the safety of multiple, ascending dose levels of MTX-101by evaluating the incidence, severity, and seriousness of treatment-emergent adverse events'}], 'secondaryOutcomes': [{'measure': 'pharmacokinetics (PK) of MTX-101', 'timeFrame': 'Enrollment to 11 weeks following the last dose', 'description': 'Characterize the pharmacokinetics (PK) of MTX-101 by measuring the maximum time of occurrence for maximum plasma drug concentration (Cmax)'}, {'measure': 'pharmacokinetics (PK) of MTX-101', 'timeFrame': 'Enrollment to 11 weeks following the last dose', 'description': 'Characterize the pharmacokinetics (PK) of MTX-101 by measuring the time of occurrence for maximum plasma drug concentration (Tmax).'}, {'measure': 'pharmacokinetics (PK) of MTX-101', 'timeFrame': 'Enrollment to 11 weeks following the last dose', 'description': 'Characterize the pharmacokinetics (PK) of MTX-101 by measuring the maximum plasma drug concentration (Cmax), minimum plasma drug concentration (Cmin), and area under the plasma drug concentration versus time curve from time 0 to last measurable concentration (AUC(0-t))'}, {'measure': 'anti-drug antibody (ADA) formation', 'timeFrame': 'Enrollment to 11 weeks following the last dose', 'description': "Evaluate incidence of anti-drug antibody (ADA) formation by measuring the detect the presence of anti-MTX-101 antibodies in participant's blood."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteers', 'Celiac', 'Type 1 Diabetes'], 'conditions': ['Healthy Volunteers', 'Celiac Disease', 'Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'First in human study to understand the potential side effects of MTX-101, how long MTX-101 lasts in the human body, and how MTX-101 affects specific human immune cells.', 'detailedDescription': 'This is a prospective, multi-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MTX-101 in healthy adults (HA) and participants with celiac disease (CeD) and type 1 diabetes (T1D). This study will enroll HAs only in Part A and CeD and T1D patients only in Part B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults, age ≥ 18 and ≤ 65 years at the time of anticipated dosing (Day 1).\n* Healthy individuals without known current or chronic medical conditions, including no history of any autoimmune diseases, in the opinion of the Investigator.\n* Body mass index (BMI) ≥ 18 kg/m2 and ≤ 32 kg/m2.\n* Body weight ≥ 45and ≤ 100 kg.\n* Negative Coronavirus Disease 2019 (COVID-19) test within 24 hours prior to each dose.\n* Persons of child-bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective method(s) of birth control from Day 1 through the duration of the study.\n\nExclusion Criteria:\n\n* Clinically significant findings in physical examination (PE), vital signs (blood pressure, heart rate, and body temperature), electrocardiogram (ECG), and safety laboratory parameters at Screening in the opinion of the Investigator.\n* Renal function calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation with estimated glomerular filtration rate (eGFR) \\< 90 mL/min/1.73 m2 or abnormal level of proteinuria detected by dipstick at the time of Screening.\n* Any disease or condition that, in the opinion of the Investigator, might significantly compromise the cardiovascular, hematological, renal, hepatic, pulmonary (including chronic asthma), endocrine (e.g., diabetes), central nervous, or gastrointestinal (including an ulcer) systems.\n* Receipt of an investigational drug within 28 days or 5 half-lives (whichever is longer) of the investigational drug(s) prior to Day 1.\n* Positive serology for human immunodeficiency virus (HIV) type 1 or 2, hepatitis (Hep) B surface antigen, or Hep C.\n* Positive test results for drug screen, including alcohol, at the time of Screening or on Day 1 prior to randomization.\n* Use of tobacco or nicotine-containing products more than the equivalent of 5 cigarettes/week within 30 days prior to (first) dosing.\n\nParticipants must abstain from nicotine use while inpatient.\n\n* History of receiving a live vaccine within 1 month of Screening.\n* History of splenectomy.\n* History of COVID or influenza vaccine within 2 weeks prior to Screening.\n* Planning to receive any vaccinations during the study period.\n* History of recurrent infections of uncertain cause.'}, 'identificationModule': {'nctId': 'NCT06324604', 'briefTitle': 'Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mozart Therapeutics Australia Pty Ltd'}, 'officialTitle': 'Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients', 'orgStudyIdInfo': {'id': 'MT-101-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort AS1 - Healthy Volunteers', 'description': '(n = 6): MTX-101, Dose level 1 IV or Placebo IV, Single dose', 'interventionNames': ['Drug: Placebo', 'Drug: MTX-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort AS2 - Healthy Volunteers', 'description': '(n = 6): MTX-101, Dose Level 2 IV or Placebo IV, Single dose', 'interventionNames': ['Drug: Placebo', 'Drug: MTX-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort AS3 - Healthy Vounteers', 'description': '(n = 6): MTX-101, Dose Level 3 IV or Placebo IV, single dose', 'interventionNames': ['Drug: Placebo', 'Drug: MTX-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort AS4 - Healthy Volunteers', 'description': '(n =6): MTX-101, Dose Level 4 IV or Placebo IV, single dose', 'interventionNames': ['Drug: Placebo', 'Drug: MTX-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort AS5 - Healthy Volunteers', 'description': '(n = 6): MTX-101, Dose level 6 IV or Placebo IV, Single Dose', 'interventionNames': ['Drug: Placebo', 'Drug: MTX-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort AM1 - Healthy Volunteers', 'description': 'Cohort AM1 (n = 6): MTX-101, Dose Level 5 IV or Placebo IV, dosed on Days 1 and 22 for a total of 2 doses', 'interventionNames': ['Drug: Placebo', 'Drug: MTX-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort B8 - Celiac Disease or Type 1 Diabetes Patients', 'description': '* Dose Group 1 (n = 6): MTX-101 Dose Level 4 IV Day 1 and 29, placebo IV Day 57\n* Dose Group 2 (n = 6): Placebo IV Day 1, MTX-101 Dose Level 3 IV Day 29 and 57', 'interventionNames': ['Drug: Placebo', 'Drug: MTX-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort B9 -Celiac Disease or Type 1 Diabetes Patients', 'description': 'Dose Group 1 (n = 6): MTX-101 Dose Level 5 IV Days 1 and 29 Dose Group 2 (n = 6): Placebo IV Day 1, MTX-101 Dose Level 5 IV (or the maximum tolerated dose in Part A MAD) Day 29', 'interventionNames': ['Drug: Placebo', 'Drug: MTX-101']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Cohort AM1 - Healthy Volunteers', 'Cohort AS1 - Healthy Volunteers', 'Cohort AS2 - Healthy Volunteers', 'Cohort AS3 - Healthy Vounteers', 'Cohort AS4 - Healthy Volunteers', 'Cohort AS5 - Healthy Volunteers', 'Cohort B8 - Celiac Disease or Type 1 Diabetes Patients', 'Cohort B9 -Celiac Disease or Type 1 Diabetes Patients']}, {'name': 'MTX-101', 'type': 'DRUG', 'description': 'MTX-101 (bispecific CD8 Treg modulator)', 'armGroupLabels': ['Cohort AM1 - Healthy Volunteers', 'Cohort AS1 - Healthy Volunteers', 'Cohort AS2 - Healthy Volunteers', 'Cohort AS3 - Healthy Vounteers', 'Cohort AS4 - Healthy Volunteers', 'Cohort AS5 - Healthy Volunteers', 'Cohort B8 - Celiac Disease or Type 1 Diabetes Patients', 'Cohort B9 -Celiac Disease or Type 1 Diabetes Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4066', 'city': 'Auchenflower', 'state': 'Queensland', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Australia', 'facility': 'Wesley Research Institute', 'geoPoint': {'lat': -27.47443, 'lon': 152.99213}}, {'zip': '4006', 'city': 'Herston', 'state': 'Queensland', 'status': 'COMPLETED', 'country': 'Australia', 'facility': 'Nucleus Network Brisbane', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '3050', 'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'John Wentworth, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Royal Melbourne Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Box Hill', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Dr Swee Lin Chen Yi Mei', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Eastern Health; Box Hill Hospital'}], 'centralContacts': [{'name': 'Heather Director, Clinical Operations', 'role': 'CONTACT', 'email': 'hwroe@mozart-tx.com', 'phone': '1-253-358-9586'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mozart Therapeutics Australia Pty Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}