Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 4:28 PM
Study NCT ID:
NCT05366634
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2022-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Ascending Dose Study to Evaluate MDK-703 in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2022-05-04', 'studyFirstSubmitQcDate': '2022-05-04', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of adverse events after single injection of MDK-703', 'timeFrame': '8 weeks', 'description': 'Adverse events after single Injection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'MDK-703-101 is a single ascending dose study, to determine the safety, tolerability, and PK/PD of MDK-703 in healthy adult subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs.\n\nExclusion Criteria:\n\n1\\. Significant history or clinical manifestation of any metabolic, autoimmune, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder.'}, 'identificationModule': {'nctId': 'NCT05366634', 'briefTitle': 'A Single Ascending Dose Study to Evaluate MDK-703 in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medikine, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Placebo-controlled, Single-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDK-703 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'MDK-703-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Single injection of MDK-703 (dose level 1) or matching placebo', 'interventionNames': ['Biological: MDK-703 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Single injection of MDK-703 (dose level 2) or matching placebo', 'interventionNames': ['Biological: MDK-703 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Single injection of MDK-703 (dose level 3) or matching placebo', 'interventionNames': ['Biological: MDK-703 or Placebo']}], 'interventions': [{'name': 'MDK-703 or Placebo', 'type': 'BIOLOGICAL', 'description': 'Injection', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Medikine Clinical Site', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medikine, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medikine Australia Pty Ltd.', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}