Ignite Creation Date:
2025-12-24 @ 4:55 PM
Ignite Modification Date:
2026-01-02 @ 9:41 AM
Study NCT ID:
NCT04844450
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2021-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2021-04-13', 'studyFirstSubmitQcDate': '2021-04-13', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Signs and Symptoms/ Adverse Events (AEs)', 'timeFrame': 'Up to Day 182', 'description': 'Number of participants with treatment-emergent signs and symptoms/adverse events (including allergic reactions/hypersensitivity and local injection site reactions) will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Treatment-emergent adverse events (TEAEs) are defined as AEs with onset or worsening on or after date of first dose of study treatment.'}, {'measure': 'Number of Participants With Change From Baseline in Vital Signs Abnormalities', 'timeFrame': 'Baseline, up to Day 168', 'description': 'Number of participants with change from baseline in vital signs abnormalities including temperature, heart rate, respiratory rate, and blood pressure (supine) will be reported.'}, {'measure': 'Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities', 'timeFrame': 'Baseline, up to Day 168', 'description': 'Number of participants with change from baseline in clinical laboratory abnormalities including hematology, chemistry and urinalysis will be reported.'}, {'measure': 'Number of Participants With Change From Baseline in Physical Examination Abnormalities', 'timeFrame': 'Baseline, up to Day 168', 'description': 'Number of participants with change from baseline in physical examination abnormalities will be reported.'}, {'measure': 'Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Baseline, up to Day 168', 'description': 'Number of participants with change from baseline in ECG abnormalities will be reported.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Liver Fat Content', 'timeFrame': 'Baseline, weeks 6, 12, 18 and 24', 'description': 'Percent change from baseline in liver fat content will be reported.'}, {'measure': 'Plasma Concentration of JNJ-75220795 Over Time', 'timeFrame': 'SAD: Predose, up to Day 3 and MAD: Predose, up to Day 86', 'description': 'Plasma samples will be analyzed to determine concentrations of JNJ-75220795.'}, {'measure': 'Percentage of Participants With Treatment-emergent Anti Drug Antibodies (ADA)', 'timeFrame': 'Up to Day 168', 'description': 'Percentage of participants with treatment-emergent ADA will be assessed using a validated assay for ADA analysis.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fatty Liver Disease']}, 'referencesModule': {'references': [{'pmid': '40881642', 'type': 'DERIVED', 'citation': 'Wang C, Guo P, Liu X, Xu X, Zou L, Meng S, Guo Q, Wen Q, Yang C. Association Between PNPLA3 Inhibition and Gout: A Drug Target Mendelian Randomization Study. Int J Endocrinol. 2025 Aug 20;2025:6664846. doi: 10.1155/ije/6664846. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the safety and tolerability of single and multiple subcutaneous (SC) doses of JNJ-75220795.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with certain genetic predisposition to non-alcoholic fatty liver disease (NAFLD) determined at screening\n* Presence of liver steatosis at screening\n* Participants on anti-hypertensive and/or lipid lowering medications and/or glucose lowering medications must be on stable dose(s) for at least 4 weeks prior to screening\n* Weight stable defined as no more than 5% body weight loss or gain within 3 months prior to screening and no more than 5% body weight loss or gain from screening to randomization\n\nExclusion Criteria:\n\n* Known allergies, hypersensitivity, or intolerance to JNJ-75220795 or its excipients\n* History of hepatitis B surface antigen (HbsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HbsAg or anti-HCV at screening\n* History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening'}, 'identificationModule': {'nctId': 'NCT04844450', 'briefTitle': 'A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered JNJ-75220795', 'orgStudyIdInfo': {'id': 'CR108997'}, 'secondaryIdInfos': [{'id': '75220795NAS1001', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Ascending Dose (SAD)', 'description': 'Participants in cohorts 1-5 and cohorts 3a-5a will receive subcutaneous (SC) injection of single dose (Part A) of JNJ-75220795 or matching placebo.', 'interventionNames': ['Drug: JNJ-75220795', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Multiple Ascending Dose (MAD)', 'description': 'Participants in cohorts 6-8 will receive SC injection of 2 doses (Part B) of JNJ-75220795 or matching placebo. Participants in cohorts 9-11 will receive SC injection of 4 doses (Part C) of JNJ-75220795 or matching placebo.', 'interventionNames': ['Drug: JNJ-75220795', 'Drug: Placebo']}], 'interventions': [{'name': 'JNJ-75220795', 'type': 'DRUG', 'description': 'JNJ-75220795 will be administered subcutaneously.', 'armGroupLabels': ['Multiple Ascending Dose (MAD)', 'Single Ascending Dose (SAD)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo will be administered subcutaneously.', 'armGroupLabels': ['Multiple Ascending Dose (MAD)', 'Single Ascending Dose (SAD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Centers of America, LLC', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Endeavor Clinical Trials, LLC', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'ipdSharingStatementModule': {'url': 'https://www.janssen.com/clinical-trials/transparency', 'ipdSharing': 'YES', 'description': 'The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \\& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}