Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT04994912
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2021-07-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
First in Human Study of EI-001 Monoclonal Antibody in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000604216', 'term': 'BL-EI001'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2021-07-19', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety assessment', 'timeFrame': 'Day 1', 'description': 'to assess blood pressure'}, {'measure': 'safety assessment', 'timeFrame': 'Day 1', 'description': 'to assess heart rate'}, {'measure': 'safety assessment', 'timeFrame': 'Day 1', 'description': 'to assess respiratory rate'}], 'secondaryOutcomes': [{'measure': 'PK assessment', 'timeFrame': 'Day 1', 'description': 'To assess Maximum observed concentration (Cmax)'}, {'measure': 'PK assessment', 'timeFrame': 'Day 1', 'description': 'To assess time to maximum observed drug concentration (Tmax)'}, {'measure': 'PK assessment', 'timeFrame': 'Day 1', 'description': 'to assess AUC from time zero to the last measurable concentration (AUC0-t)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'A First-in-Human, Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-001 in Healthy Volunteers.', 'detailedDescription': 'To assess the safety and tolerability of single ascending intravenous (IV) doses of EI-001 in healthy volunteers\n\nTo assess the pharmacokinetics (PK) of single ascending IV doses of EI-001 in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy male or female 18 to ≤ 55 years old at the time of consent.\n2. Healthy on the basis of physical examination, medical history, vital signs, laboratory values and 12-lead ECG performed at Screening. The participant may be included only if the investigator judges any abnormalities or deviations from normal to be not clinically significant.\n\nExclusion Criteria:\n\n1. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures or interfere with study assessments.\n2. Have received any IP within 30 days or 5 half-lives prior to Screening (4 months if the previous drug was a new chemical entity), whichever is longer."}, 'identificationModule': {'nctId': 'NCT04994912', 'briefTitle': 'First in Human Study of EI-001 Monoclonal Antibody in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Elixiron Immunotherapeutics (Hong Kong) Ltd.'}, 'officialTitle': 'Title of Study: A First-in-Human, Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-001 in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'EI-001-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EI-001', 'description': 'IV infusion', 'interventionNames': ['Drug: EI-001']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'IV infusion', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'EI-001', 'type': 'DRUG', 'description': 'EI-001 IV infusion', 'armGroupLabels': ['EI-001']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo IV infusion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Nucleus Network Pty Ltd', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Huashan Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elixiron Immunotherapeutics (Hong Kong) Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}