Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT07232004
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate How the Study Drug Moves Through the Body, Adverse Events, and How the Body Tolerates ABBV-547 Injections
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', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 87}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-12', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events (AEs)', 'timeFrame': 'Up to Approximately Day 365', '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteer', 'ABBV-547'], 'conditions': ['Healthy Volunteer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M26-058', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess how safe, effective, and tolerable ABBV-547 is in adult participants in the United States and Japan.\n\nThere will be 2 parts to this study. In Part 1, participants are placed in one of 3 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 4 chance participants will receive placebo. In Part 2, participants are placed in one of 3 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 7 chance participants will receive placebo. Approximately 87 adult participants will be enrolled at approximately 21 sites in the United States and Japan.\n\nParticipants will be administered one dose of ABBV-547 or placebo.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\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* Part 1: BMI is \\>= 18.0 to \\<= 29.9 kg/m\\^2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* Part 2: must have discontinued use of phototherapy (e.g., UVA or UVB) at least 2 weeks prior to the baseline visit (Day 1) and PUVA phototherapy at least 4 weeks prior to the baseline visit (Day 1).\n\nExclusion Criteria:\n\n* History of any clinically significant sensitivity or allergy to any medication or food.\n* Part 2: uses any herbal supplements within the 2-week period prior to study treatment administration.\n* Part 2: received any biologics including investigational agents within 2.5 half-lives prior to Baseline.'}, 'identificationModule': {'nctId': 'NCT07232004', 'briefTitle': 'A Study to Evaluate How the Study Drug Moves Through the Body, Adverse Events, and How the Body Tolerates ABBV-547 Injections', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A First-in-Human, Phase 1a/b, Single-Dose Study of ABBV-547 to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability in Adult Participants and Efficacy in Adult Participants', 'orgStudyIdInfo': {'id': 'M26-058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1: ABBV-547 & Placebo', 'description': 'Participants will receive either ABBV-547 or placebo.', 'interventionNames': ['Drug: ABBV-547', 'Drug: ABBV-547 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2: ABBV-547 & Placebo', 'description': 'Participants will receive either ABBV-547 or placebo.', 'interventionNames': ['Drug: ABBV-547', 'Drug: ABBV-547 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3: ABBV-547 & Placebo', 'description': 'Participants will receive either ABBV-547 or placebo.', 'interventionNames': ['Drug: ABBV-547', 'Drug: ABBV-547 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4: ABBV-547 & Placebo', 'description': 'Participants will receive either ABBV-547 or placebo.', 'interventionNames': ['Drug: ABBV-547', 'Drug: ABBV-547 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5: ABBV-547 & Placebo', 'description': 'Participants will receive either ABBV-547 or placebo.', 'interventionNames': ['Drug: ABBV-547', 'Drug: ABBV-547 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group 6: ABBV-547 & Placebo', 'description': 'Participants will receive either ABBV-547 or placebo.', 'interventionNames': ['Drug: ABBV-547', 'Drug: ABBV-547 Placebo']}], 'interventions': [{'name': 'ABBV-547', 'type': 'DRUG', 'description': 'Injection', 'armGroupLabels': ['Group 1: ABBV-547 & Placebo', 'Group 2: ABBV-547 & Placebo', 'Group 3: ABBV-547 & Placebo', 'Group 4: ABBV-547 & Placebo', 'Group 5: ABBV-547 & Placebo', 'Group 6: ABBV-547 & Placebo']}, {'name': 'ABBV-547 Placebo', 'type': 'DRUG', 'description': 'Injection', 'armGroupLabels': ['Group 1: ABBV-547 & Placebo', 'Group 2: ABBV-547 & Placebo', 'Group 3: ABBV-547 & Placebo', 'Group 4: ABBV-547 & Placebo', 'Group 5: ABBV-547 & Placebo', 'Group 6: ABBV-547 & Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'CenExel ACT- Anaheim Clinical Trials /ID# 279612', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '60030', 'city': 'Grayslake', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Acpru /Id# 278638', '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'}}}}