Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-26 @ 11:27 PM
Study NCT ID:
NCT03715192
Status:
COMPLETED
Last Update Posted:
2019-12-23
First Post:
2018-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety Study of LY3462817 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-20', 'studyFirstSubmitDate': '2018-10-19', 'studyFirstSubmitQcDate': '2018-10-19', 'lastUpdatePostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug', 'timeFrame': 'Baseline through to final follow-up at approximately Week 12', 'description': 'A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: Maximum Concentration (Cmax) of LY3462817', 'timeFrame': 'Baseline through to final follow-up at approximately Week 12', 'description': 'Pharmacokinetics: Cmax of LY3462817'}, {'measure': 'Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3462817', 'timeFrame': 'Baseline through to final follow-up at approximately Week 12', 'description': 'Pharmacokinetics: AUC of LY3462817'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to determine how safe and how well tolerated LY3462817 is when given intravenously (IV) (into a vein) and subcutaneously (SC) (just under the skin) to healthy participants. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive 1 dose of LY3462817 or placebo. The study will last about 16 weeks, including screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Overtly healthy male or a female who cannot get pregnant\n* Have a body mass index (BMI) of 18 to 32 kilogram per square meter (kg/m²), inclusive, at screening\n* Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study\n* Weight at least 45 kilograms (kg)\n\nExclusion Criteria:\n\n* Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study\n* Have previously participated or withdrawn from this study\n* Have cancer or a malignant disease in the past 5 years\n* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study\n* Are unwilling to receive study drug administration by injections or through the veins'}, 'identificationModule': {'nctId': 'NCT03715192', 'briefTitle': 'A Safety Study of LY3462817 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'Single-Ascending Dose, Safety, Tolerability, and Pharmacokinetic Study of LY3462817', 'orgStudyIdInfo': {'id': '17089'}, 'secondaryIdInfos': [{'id': 'J1A-MC-KDAB', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY3462817 - IV', 'description': 'Escalating doses of LY3462817 administered as a single intravenous (IV) infusion in healthy participants', 'interventionNames': ['Biological: LY3462817 IV']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Normal saline administered as a single IV infusion in healthy participants', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'LY3462817 - SC', 'description': 'Single dose of LY3462817 administered as subcutaneous (SC) injections in healthy participants', 'interventionNames': ['Biological: LY3462817 SC']}], 'interventions': [{'name': 'LY3462817 IV', 'type': 'BIOLOGICAL', 'description': 'Administered IV', 'armGroupLabels': ['LY3462817 - IV']}, {'name': 'LY3462817 SC', 'type': 'BIOLOGICAL', 'description': 'Administered SC', 'armGroupLabels': ['LY3462817 - SC']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138623', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Lilly Nus Centre for Clin Pharmacology', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}