Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-26 @ 9:04 AM
Study NCT ID:
NCT07219368
Status:
RECRUITING
Last Update Posted:
2025-11-04
First Post:
2025-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-in-Human Single and Multiple Ascending Dose Study of MT-201
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C460839', 'term': 'adecatumumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double-Blind'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-31', 'studyFirstSubmitDate': '2025-10-17', 'studyFirstSubmitQcDate': '2025-10-17', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-24', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with non-SAEs and SAES', 'timeFrame': 'Up to 40 weeks', 'description': 'Incidence of adverse events, clinically significant laboratory abnormalities, clinically significant electrocardiogram, vital signs, and physical examination abnormalities.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MT-201', 'Phase 1'], 'conditions': ['Healthy Volunteer']}, 'descriptionModule': {'briefSummary': 'First-in-human study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single and multiple doses of MT-201 in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'genderBased': True, 'genderDescription': 'male and female (of non-childbearing potential only)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male participant or female participant of nonchildbearing potential between 19 and 55 years of age (inclusive) at the time of signing informed consent.\n2. Female participants must be of nonchildbearing potential, defined as postmenopausal or surgically sterile, and have official documentation, at least 6 months prior to the first dose.\n3. Male participants with female partners of childbearing potential who are involved in heterosexual intercourse or activities that could lead to pregnancy must use barrier method of contraception (male condom) and refrain from sperm donation.\n4. Good general health.\n5. Able to provide written informed consent and understand and comply with the requirements of the study.\n\nExclusion Criteria:\n\n1. History or presence of any clinically significant organ system disease.\n2. Abnormal laboratory assessments, physical exam of ECG outside the normal range that is judged by the Investigator to be clinically significant.\n3. History of alcohol or drug abuse within the past 24 months.\n4. Current use or history of regular tobacco, or nicotine-containing products within 3 months prior to screening.\n5. Administration or use of any investigational drug or device within 30 days preceding the first dose of study drug administration.\n6. Blood donation within 60 days prior to dosing or plasma donation within 14 days prior to dosing.'}, 'identificationModule': {'nctId': 'NCT07219368', 'briefTitle': 'A First-in-Human Single and Multiple Ascending Dose Study of MT-201', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mirador Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single and Multiple Doses of MT-201 in Healthy Participants', 'orgStudyIdInfo': {'id': 'MT-201-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Ascending Dose of MT-201', 'description': 'To assess the safety and tolerability of single intravenous/subcutaneous doses of MT-201', 'interventionNames': ['Drug: MT-201']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Ascending Dose of MT-201', 'description': 'To assess the safety and tolerability of multiple intravenous/subcutaneous doses of MT-201', 'interventionNames': ['Drug: MT-201']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Single Ascending Dose Placebo Arm', 'description': 'To assess the safety and tolerability of single intravenous/subcutaneous doses of placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Multiple Ascending Dose Placebo', 'description': 'To assess the safety and tolerability of multiple intravenous/subcutaneous doses of placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'MT-201', 'type': 'DRUG', 'description': 'MT-201', 'armGroupLabels': ['Multiple Ascending Dose of MT-201', 'Single Ascending Dose of MT-201']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Multiple Ascending Dose Placebo', 'Single Ascending Dose Placebo Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92121', 'city': 'San Diego', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mirador Clinical Department', 'role': 'CONTACT', 'email': 'ClinicalTrials@Miradortx.com', 'phone': '844-206-4980'}, {'name': 'Toll-Free Number', 'role': 'CONTACT'}], 'facility': 'Mirador Clinical Department, San Diego, California 92121', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'centralContacts': [{'name': 'Toll-Free Number', 'role': 'CONTACT', 'email': 'clinicaltrials@miradortx.com', 'phone': '844-206-4980'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mirador Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}