Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-25 @ 5:12 PM
Study NCT ID:
NCT07136103
Status:
RECRUITING
Last Update Posted:
2025-09-02
First Post:
2025-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-08-15', 'studyFirstSubmitQcDate': '2025-08-15', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax) of ABBV-277', 'timeFrame': 'Up to approximately 9 days', 'description': 'Cmax of ABBV-277'}, {'measure': 'Time to Cmax (Tmax) of ABBV-277', 'timeFrame': 'Up to approximately 9 days', 'description': 'Tmax of ABBV-277'}, {'measure': 'Terminal Phase Elimination Rate Constant (Beta) of ABBV-277', 'timeFrame': 'Up to approximately 9 days', 'description': 'Terminal phase elimination rate constant (beta) of ABBV-277'}, {'measure': 'Terminal Phase Elimination Half-Life (t1/2) of ABBV-277', 'timeFrame': 'Up to approximately 9 days', 'description': 'Terminal phase elimination half-life of ABBV-277'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-277', 'timeFrame': 'Up to approximately 9 days', 'description': 'AUCt of ABBV-277'}, {'measure': 'Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-277', 'timeFrame': 'Up to approximately 9 days', 'description': 'AUCinf of ABBV-277'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to Day 196', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteers', 'ABBV-277'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M24-934', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK ) properties following a single dose of ABBV-277 in healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body weight ≥ 35 kg\n* Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m\\^2 after rounding to the tenths decimal.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile neurological examination, and a 12-lead ECG\n\nExclusion Criteria:\n\n* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.\n* Participant must meet pregnancy/conception/partner considerations criteria as detailed in the eligibility section.\n* Participants using any medications, vitamins and/or herbal supplements within the 14-day period prior to study drug administration or within 5 half-lives of the respective medication, whichever is longer.\n* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.\n* History of suicidal ideation currently or within one year prior to study drug administration as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the C - SSRS completed at screening, or any history of suicide attempts within the last two years.'}, 'identificationModule': {'nctId': 'NCT07136103', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A First-in-Human Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'M24-934'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: ABBV-277-Dose A', 'description': 'Participants will receive ABBV-277 Dose A on day 1 and followed for 196 days', 'interventionNames': ['Drug: ABBV-277']}, {'type': 'EXPERIMENTAL', 'label': 'Group 1: Placebo', 'description': 'Participants will receive Placebo on day 1 and followed for 196 days', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: ABBV-277-Dose B', 'description': 'Participants will receive ABBV-277 Dose B on day 1 and followed for 196 days', 'interventionNames': ['Drug: ABBV-277']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: Placebo', 'description': 'Participants will receive Placebo on day 1 and followed for 196 days', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: ABBV-277-Dose C', 'description': 'Participants will receive ABBV-277 Dose C on day 1 and followed for 196 days', 'interventionNames': ['Drug: ABBV-277']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: Placebo', 'description': 'Participants will receive Placebo on day 1 and followed for 196 days', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: ABBV-277-Dose D', 'description': 'Participants will receive ABBV-277 Dose D on day 1 and followed for 196 days', 'interventionNames': ['Drug: ABBV-277']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: Placebo', 'description': 'Participants will receive Placebo on day 1 and followed for 196 days', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5: ABBV-277-Dose E', 'description': 'Participants will receive ABBV-277 Dose E on day 1 and day 2 and followed for 196 days', 'interventionNames': ['Drug: ABBV-277']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5: Placebo', 'description': 'Participants will receive Placebo on day 1 and day 2 and followed for 196 days', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ABBV-277', 'type': 'DRUG', 'description': '• Intravenous (IV) infusion', 'armGroupLabels': ['Group 1: ABBV-277-Dose A', 'Group 2: ABBV-277-Dose B', 'Group 3: ABBV-277-Dose C', 'Group 4: ABBV-277-Dose D', 'Group 5: ABBV-277-Dose E']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '• Intravenous (IV) infusion', 'armGroupLabels': ['Group 1: Placebo', 'Group 2: Placebo', 'Group 3: Placebo', 'Group 4: Placebo', 'Group 5: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60030', 'city': 'Grayslake', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Acpru /Id# 265681', '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'}}}}