Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:36 PM
Study NCT ID:
NCT07413133
Status:
RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess How the Body Absorbs ABBV-8736 Subcutaneous Injections Relative to Intravenous Injections in Adult Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to At Least 3 Months', 'description': 'An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.'}, {'measure': 'Maximum Observed Serum Concentration (Cmax) of ABBV-8736', 'timeFrame': 'Up to At Least 3 Months', 'description': 'Cmax of ABBV-8736.'}, {'measure': 'Time to Maximum Observed Serum Concentration (Tmax) of ABBV-8736', 'timeFrame': 'Up to At Least 3 Months', 'description': 'Tmax of ABBV-8736.'}, {'measure': 'Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time Last (AUClast) of ABBV-8736', 'timeFrame': 'Up to At Least 3 Months', 'description': 'AUClast of ABBV-8736.'}, {'measure': 'AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-8736', 'timeFrame': 'Up to At Least 3 Months', 'description': 'AUCinf of ABBV-8736.'}, {'measure': 'Terminal Phase Elimination Rate Constant (β) of ABBV-8736', 'timeFrame': 'Up to At Least 3 Months', 'description': 'β of ABBV-8736.'}, {'measure': 'Terminal Elimination Half-Life (t1/2) of ABBV-8736', 'timeFrame': 'Up to At Least 3 Months', 'description': 't1/2 of ABBV-8736.'}, {'measure': 'Apparent Clearance of the Analyte in Serum (CL) of ABBV-8736', 'timeFrame': 'Up to At Least 3 Months', 'description': 'CL of ABBV-8736.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteer', 'ABBV-8736'], 'conditions': ['Healthy Volunteer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M25-478', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the pharmacokinetics (PK), bioavailability, immunogenicity, safety, and tolerability of ABBV-8736 following subcutaneous (SC) administration relative to intravenous (IV) administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) is \\>= 18.0 to \\<= 32.0 kg/m2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* Body weight \\>= 35 kg.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).\n\nExclusion Criteria:\n\n* Participant requires any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements, on a regular basis.\n* Participant uses any medications, vitamins and/or herbal supplements within the 14-day period prior to study treatment administration.\n* Participant has received any treatment by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study treatment administration.\n* Participant has prior exposure to a Triggering Receptor Expressed on Myeloid Cells 1 (TREM1) agent.'}, 'identificationModule': {'nctId': 'NCT07413133', 'briefTitle': 'A Study to Assess How the Body Absorbs ABBV-8736 Subcutaneous Injections Relative to Intravenous Injections in Adult Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1 Pharmacokinetic Study in Healthy Adult Volunteers to Evaluate the Bioavailability of ABBV-8736 Following Subcutaneous Administration Relative to Intravenous Administration', 'orgStudyIdInfo': {'id': 'M25-478'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1: Intravenous (IV) ABBV-8736', 'description': 'Participants will receive IV ABBV-8736 on Day 1.', 'interventionNames': ['Drug: ABBV-8736']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Subcutaneous (SC) ABBV-8736', 'description': 'Participants will receive SC ABBV-8736 on Day 1.', 'interventionNames': ['Drug: ABBV-8736']}], 'interventions': [{'name': 'ABBV-8736', 'type': 'DRUG', 'description': 'Intravenous Injection', 'armGroupLabels': ['Arm 1: Intravenous (IV) ABBV-8736']}, {'name': 'ABBV-8736', 'type': 'DRUG', 'description': 'Subcutaneous Injection', 'armGroupLabels': ['Arm 2: Subcutaneous (SC) ABBV-8736']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'CenExel ACT- Anaheim Clinical Trials /ID# 280481', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '60030', 'city': 'Grayslake', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Acpru /Id# 280382', 'geoPoint': {'lat': 42.34447, 'lon': -88.04175}}], 'centralContacts': [{'name': 'ABBVIE CALL CENTER', 'role': 'CONTACT', 'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '844-663-3742'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}