Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT07096193
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019701', 'term': 'Hepatitis D, Chronic'}], 'ancestors': [{'id': 'D003699', 'term': 'Hepatitis D'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 107}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-07-24', 'studyFirstSubmitQcDate': '2025-07-24', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events', 'timeFrame': 'Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up'}, {'measure': 'Phase 1 and 2: Percentage of Participants With Treatment-emergent Serious Adverse Events', 'timeFrame': 'Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up'}, {'measure': 'Phase 1 and 2: Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities', 'timeFrame': 'Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up'}, {'measure': 'Phase 1: Serum Pharmacokinetic (PK) parameter; AUClast of GS-4321', 'timeFrame': 'First dose up to 24 Weeks', 'description': 'AUClast is defined as the area under the concentration versus time curve from time zero to the last quantifiable concentration.'}, {'measure': 'Phase 1: Serum PK Parameter: AUCinf', 'timeFrame': 'First dose up to 24 Weeks', 'description': 'AUCinf is defined as the area under the concentration versus time curve extrapolated to infinite time.'}, {'measure': 'Phase 1: Serum PK Parameter: Cmax', 'timeFrame': 'First dose up to 24 Weeks', 'description': 'Cmax is defined as the maximum observed concentration of drug.'}, {'measure': 'Phase 1: Serum PK Parameter: Tmax', 'timeFrame': 'First dose up to 24 Weeks', 'description': 'Tmax is defined as the time (observed time point) of Cmax.'}, {'measure': 'Phase 1: Serum PK Parameter: t1/2', 'timeFrame': 'First dose up to 24 Weeks'}, {'measure': 'Phase 2: Proportion of Participants with Combined Response', 'timeFrame': 'Up to 96 Weeks', 'description': 'Combined Response is defined as undetectable hepatitis delta virus (HDV) RNA or ≥ 2 log10 decrease in HDV RNA from baseline and normal alanine aminotransferase (ALT) normalization (ALT \\< upper limit of normal (ULN) at week 24).'}], 'secondaryOutcomes': [{'measure': 'Phase 1: Proportion of Participants who Develop Antidrug Antibody (ADAs) After Administration of a Single Dose of GS-4321 and ADA Titer Characterization', 'timeFrame': 'First dose up to 24 Weeks', 'description': 'ADA Titer characterization will include proportion of participants with ADA incidence, prevalence, persistence, and transience .'}, {'measure': 'Phase 2: Serum PK Parameters AUCtau of GS-4321', 'timeFrame': 'Up to 96 weeks'}, {'measure': 'Phase 2: Serum PK Parameters Cmax of GS-4321', 'timeFrame': 'Up to 96 Weeks'}, {'measure': 'Phase 2: Serum PK Parameters Tmax of GS-4321', 'timeFrame': 'Up to 96 Weeks'}, {'measure': 'Phase 2: Serum PK Parameters Ctrough of GS-4321', 'timeFrame': 'Up to 96 Weeks'}, {'measure': 'Phase 2: Proportion of Participants With Undetectable HDV RNA or ≥ 2 log10 Decrease in HDV RNA From Baseline and normal ALT (ALT < ULN).', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 36, 48, 60, 72, 84, and 96'}, {'measure': 'Phase 2: Change From Baseline in HDV RNA at Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96', 'timeFrame': 'Baseline, Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96'}, {'measure': 'Phase 2: Proportion of Participants With Undetectable HDV RNA', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96'}, {'measure': 'Proportion of Participants With undetectable HDV RNA or ≥ 2 log10 Decrease in HDV From Baseline', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84 and 96'}, {'measure': 'Phase 2: Change From Baseline in Liver Stiffness by Elastography at Weeks 24, 48, and 96', 'timeFrame': 'Weeks 24, 48, and 96'}, {'measure': 'Phase 2: Proportion of Participants with normal ALT', 'timeFrame': 'Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96'}, {'measure': 'Phase 2: Proportion of Participants who Develop ADAs After Administration of Multiple Doses of GS-4321 and ADA Titer Characterization', 'timeFrame': 'First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up', 'description': 'ADA Titer characterization will include proportion of participants with ADA incidence, prevalence, persistence, and transience .'}, {'measure': 'Phase 2: Characterize if Emergent Variants are Associated With Reduced Susceptibility to GS-4321 in Vitro and Virologic Failure in Participants With CHD', 'timeFrame': 'First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hepatitis Delta']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.gileadclinicaltrials.com/study?nctid=NCT07096193', 'label': 'Gilead Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'The goals of this clinical study are to first learn more about safety and dosing of the study drug GS-4321 in healthy participants. The study will then learn about the safety and effectiveness of GS-4321 in participants with chronic hepatitis delta (CHD).\n\nThe primary objective of Phase 1 of this study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of the escalating single doses of GS-4321 administered in healthy participants.\n\nThe primary objective of Phase 2 of this study is to evaluate the efficacy and safety of the multiple escalating doses of GS-4321 in participants with CHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\nPart A:\n\n* Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.\n* Have a body mass index (BMI) of ≤ 30.0 kg/m2 at screening and at admission.\n\nPart B:\n\n* Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.\n* Chronic hepatitis delta (CHD) for ≥ 6 months prior to screening, documented by prior medical history.\n* Must be receiving a commercially available entecavir, TAF, or TDF for the treatment of hepatitis B virus (HBV) infection at or prior to enrollment. Coformulation as part of a fixed-dose combination for the treatment of HIV is permitted.\n* Non-cirrhotic or compensated cirrhosis.\n* Hepatitis delta virus ribonucleic acid (HDV RNA ) \\> 100 IU/mL at screening.\n* Alanine aminotransferase (ALT) level \\> 1 × Upper limit of normal (ULN), but \\< 10 × ULN at screening.\n\nKey Exclusion Criteria:\n\nPart A:\n\n* Positive serum or urine pregnancy test.\n* Participants with plans to breastfeed during the study period.\n\nPart B:\n\n* Positive serum or urine pregnancy test.\n* Participants with plans to breastfeed during the study period.\n* Current or previous clinically decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage due to HDV or HBV.\n* Child-Turcotte-Pugh (CTP)-B or -C or a CTP score of ≥ 7.\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT07096193', 'briefTitle': 'Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gilead Sciences'}, 'officialTitle': 'Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta', 'orgStudyIdInfo': {'id': 'GS-US-567-6968'}, 'secondaryIdInfos': [{'id': '2025-522729-36', 'type': 'OTHER', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1: GS-4321', 'description': 'Participants will receive single escalating doses of GS-4321.', 'interventionNames': ['Drug: GS-4321']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 1: Placebo', 'description': 'Participants will receive placebo to match the single escalating doses of GS-4321', 'interventionNames': ['Drug: GS-4321 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: GS-4321', 'description': 'Participants will receive multiple escalating doses of GS-4321 up to 96 weeks.', 'interventionNames': ['Drug: GS-4321']}], 'interventions': [{'name': 'GS-4321', 'type': 'DRUG', 'description': 'Administered subcutaneous (SC) or intravenously IV', 'armGroupLabels': ['Phase 1: GS-4321']}, {'name': 'GS-4321 Placebo', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Phase 1: Placebo']}, {'name': 'GS-4321', 'type': 'DRUG', 'description': 'Administered SC', 'armGroupLabels': ['Phase 2: GS-4321']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': 'MD-2025', 'city': 'Chisinau', 'status': 'RECRUITING', 'country': 'Moldova', 'facility': 'PMSI Clinical Republican Hospital "Timofei Mosneaga"', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}], 'centralContacts': [{'name': 'Gilead Clinical Study Information Center', 'role': 'CONTACT', 'email': 'GileadClinicalTrials@gilead.com', 'phone': '1-833-445-3230 (GILEAD-0)'}], 'overallOfficials': [{'name': 'Gilead Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gilead Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}