Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-30 @ 9:17 AM
Study NCT ID:
NCT06311656
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2024-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian 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': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs)', 'timeFrame': 'Baseline up to 47 days', 'description': 'A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4100511 (DC-853)', 'timeFrame': 'Predose up to 47 days'}, {'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853)', 'timeFrame': 'Predose up to 47 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy asian participants and non-Asian participants. Part A consists of 2 groups and Part B, C, and D include optional groups.', 'detailedDescription': 'Part B and C added per protocol amendment (May 2024) Added Part B to explore higher dose levels and Part C to explore effects of food. Part D added per protocol amendment (June 2024) to explore higher multiple doses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female participants who are overtly healthy as determined by medical history, vital signs, and physical examination.\n* Participants of Japanese, Chinese, and Non-Asian ethnicities\n* Have a body mass index within the range of 18.0 to 32 kilograms per square meter (kg/m²). For healthy Japanese participants, have a body mass index of 18.0 to 28.0 kg/m²\n* Have venous access sufficient to allow for blood sampling\n* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures\n\nExclusion Criteria:\n\n* Have a current or recent acute, active infection\n* Had any surgical procedure within 12 weeks prior to study\n* Are immunocompromised\n* Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values\n* Are currently enrolled in a clinical study involving any experimental antibody or biologic therapy within the previous 6 months, or any other experimental therapy within 30 days before the first dose of the study intervention or during the study'}, 'identificationModule': {'nctId': 'NCT06311656', 'briefTitle': 'A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Placebo-controlled, Phase 1, Participant- and Investigator-blinded, Single- and Multiple- Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants', 'orgStudyIdInfo': {'id': '18840'}, 'secondaryIdInfos': [{'id': 'J5C-MC-FOAA', 'type': 'OTHER', 'domain': 'DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company'}, {'id': 'DCE853107', 'type': 'OTHER', 'domain': 'DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LY4100511 (DC-853) Part A Fasted', 'description': 'Single and multiple doses of LY4100511 (DC-853) administered orally.', 'interventionNames': ['Drug: LY4100511 (DC-853)']}, {'type': 'EXPERIMENTAL', 'label': 'LY4100511 (DC-853) Part B', 'description': 'Single and multiple higher doses of LY4100511 (DC-853) administered orally.', 'interventionNames': ['Drug: LY4100511 (DC-853)']}, {'type': 'EXPERIMENTAL', 'label': 'LY4100511 (DC-853) Part C (Open Label)', 'description': 'Single dose of LY4100511 (DC-853) administered orally in fed and fasted states.', 'interventionNames': ['Drug: LY4100511 (DC-853)']}, {'type': 'EXPERIMENTAL', 'label': 'LY4100511 (DC-853) Part D', 'description': 'Multiple higher doses of LY4100511 (DC-853) administered orally.', 'interventionNames': ['Drug: LY4100511 (DC-853)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered orally.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'LY4100511 (DC-853)', 'type': 'DRUG', 'description': 'Administered orally fasted', 'armGroupLabels': ['LY4100511 (DC-853) Part A Fasted']}, {'name': 'LY4100511 (DC-853)', 'type': 'DRUG', 'description': 'Administered orally fasted.', 'armGroupLabels': ['LY4100511 (DC-853) Part B']}, {'name': 'LY4100511 (DC-853)', 'type': 'DRUG', 'description': 'Administered orally fed and fasted.', 'armGroupLabels': ['LY4100511 (DC-853) Part C (Open Label)']}, {'name': 'LY4100511 (DC-853)', 'type': 'DRUG', 'description': 'Administered orally fed and fasted.', 'armGroupLabels': ['LY4100511 (DC-853) Part D']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'Altasciences Clinical Los Angeles, Inc', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}], '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': 'DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}