[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600338":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":37,"centralContacts":41,"locations":47,"responsibleParty":212,"collaborators":30,"id":214,"slug":215,"hasResults":216,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":30,"eligibilityCriteria":220,"healthyVolunteers":221,"sex":222,"minAge":223,"maxAge":224,"enrollmentInfo":225,"targetDuration":30,"studyType":228,"phases":229,"briefSummary":232,"conditions":233,"keywords":30,"overallStatus":50,"whyStopped":30,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":244},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1: GS-4321","EXPERIMENTAL","Participants will receive single escalating doses of GS-4321.",[13],"Drug: GS-4321",{"label":15,"type":16,"description":17,"interventionNames":18},"Phase 1: Placebo","PLACEBO_COMPARATOR","Participants will receive placebo to match the single escalating doses of GS-4321",[19],"Drug: GS-4321 Placebo",{"label":21,"type":10,"description":22,"interventionNames":23},"Phase 2: GS-4321","Participants will receive multiple escalating doses of GS-4321 up to 96 weeks.",[13],[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","GS-4321","Administered subcutaneous (SC) or intravenously IV",[9],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"GS-4321 Placebo","Administered SC",[15],{"type":26,"name":27,"description":33,"armGroupLabels":36,"otherNames":30},[21],[38],{"name":39,"affiliation":5,"role":40},"Gilead Study Director","STUDY_DIRECTOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":30,"email":46},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",[48,62,72,82,91,102,108,115,121,132,138,144,153,163,172,181,187,197,206],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":30},"Investigative Site","RECRUITING","Anaheim","California","92801","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-117.9145,33.83529,{"lat":60,"lon":59},{"facility":63,"status":50,"city":64,"state":65,"zip":66,"country":54,"countryCode":55,"cosmosGeoPoint":67,"geoPoint":71,"contacts":30},"University of Louisville, Clinical Trials Unit","Louisville","Kentucky","40202",{"type":57,"coordinates":68},[69,70],-85.75941,38.25424,{"lat":70,"lon":69},{"facility":73,"status":50,"city":74,"state":75,"zip":76,"country":54,"countryCode":55,"cosmosGeoPoint":77,"geoPoint":81,"contacts":30},"University of Maryland, Institute of Human Virology, Clinical Research Unit","Baltimore","Maryland","21201",{"type":57,"coordinates":78},[79,80],-76.61219,39.29038,{"lat":80,"lon":79},{"facility":83,"status":50,"city":84,"state":84,"zip":85,"country":54,"countryCode":55,"cosmosGeoPoint":86,"geoPoint":90,"contacts":30},"The New York-Presbyterian Hospital","New York","10021",{"type":57,"coordinates":87},[88,89],-74.00597,40.71427,{"lat":89,"lon":88},{"facility":92,"status":50,"city":93,"state":30,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":101,"contacts":30},"Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, SC Gastroenterologia ed Epatologia","Milan","882","Italy","IT",{"type":57,"coordinates":98},[99,100],12.59836,42.78235,{"lat":100,"lon":99},{"facility":103,"status":50,"city":104,"state":30,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"IMSP Spitalul Clinic de Boli Infectioase \"Toma Ciorba\"","Chinsinau","2004","Moldova","MD",{"facility":103,"status":50,"city":109,"state":30,"zip":105,"country":106,"countryCode":107,"cosmosGeoPoint":110,"geoPoint":114,"contacts":30},"Chisinau",{"type":57,"coordinates":111},[112,113],28.85938,47.00902,{"lat":113,"lon":112},{"facility":116,"status":50,"city":109,"state":30,"zip":117,"country":106,"countryCode":107,"cosmosGeoPoint":118,"geoPoint":120,"contacts":30},"PMSI Clinical Republican Hospital \"Timofei Mosneaga\"","MD-2025",{"type":57,"coordinates":119},[112,113],{"lat":113,"lon":112},{"facility":122,"status":50,"city":123,"state":30,"zip":124,"country":125,"countryCode":126,"cosmosGeoPoint":127,"geoPoint":131,"contacts":30},"Institutul National De Boli Infectioase Prof. Dr. Matei Bals","Bucharest","021105","Romania","RO",{"type":57,"coordinates":128},[129,130],26.10626,44.43225,{"lat":130,"lon":129},{"facility":133,"status":50,"city":123,"state":30,"zip":134,"country":125,"countryCode":126,"cosmosGeoPoint":135,"geoPoint":137,"contacts":30},"Fundatia Dr. Victor Babes","030303",{"type":57,"coordinates":136},[129,130],{"lat":130,"lon":129},{"facility":139,"status":50,"city":123,"state":30,"zip":140,"country":125,"countryCode":126,"cosmosGeoPoint":141,"geoPoint":143,"contacts":30},"Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals","21105",{"type":57,"coordinates":142},[129,130],{"lat":130,"lon":129},{"facility":145,"status":50,"city":146,"state":30,"zip":147,"country":125,"countryCode":126,"cosmosGeoPoint":148,"geoPoint":152,"contacts":30},"Gastromedica S.R.L.","Iași","700506",{"type":57,"coordinates":149},[150,151],27.6,47.16667,{"lat":151,"lon":150},{"facility":154,"status":50,"city":155,"state":30,"zip":156,"country":157,"countryCode":30,"cosmosGeoPoint":158,"geoPoint":162,"contacts":30},"Korea University Ansan Hospital","Ansan-si","425-707","South Korea",{"type":57,"coordinates":159},[160,161],126.82194,37.32361,{"lat":161,"lon":160},{"facility":164,"status":50,"city":165,"state":30,"zip":166,"country":157,"countryCode":30,"cosmosGeoPoint":167,"geoPoint":171,"contacts":30},"The Catholic University of Korea Bucheon St. Mary's Hospital","Bucheon-si","14647",{"type":57,"coordinates":168},[169,170],126.78306,37.49889,{"lat":170,"lon":169},{"facility":173,"status":50,"city":174,"state":30,"zip":175,"country":157,"countryCode":30,"cosmosGeoPoint":176,"geoPoint":180,"contacts":30},"The Catholic University of Korea, Seoul St. Mary's Hospital","Seoul","06591",{"type":57,"coordinates":177},[178,179],126.9784,37.566,{"lat":179,"lon":178},{"facility":182,"status":50,"city":174,"state":30,"zip":183,"country":157,"countryCode":30,"cosmosGeoPoint":184,"geoPoint":186,"contacts":30},"Samsung Medical Center","135-710",{"type":57,"coordinates":185},[178,179],{"lat":179,"lon":178},{"facility":188,"status":50,"city":189,"state":30,"zip":30,"country":190,"countryCode":191,"cosmosGeoPoint":192,"geoPoint":196,"contacts":30},"Ditmanson Medical Foundation Chia-Yi Christian Hospital","Chiayi City","Taiwan","TW",{"type":57,"coordinates":193},[194,195],120.44889,23.47917,{"lat":195,"lon":194},{"facility":198,"status":50,"city":199,"state":30,"zip":200,"country":190,"countryCode":191,"cosmosGeoPoint":201,"geoPoint":205,"contacts":30},"Kaohsiung Medical University Chung-Ho Memorial Hospital","Kaohsiung City","807",{"type":57,"coordinates":202},[203,204],120.31333,22.61626,{"lat":204,"lon":203},{"facility":207,"status":50,"city":199,"state":30,"zip":208,"country":190,"countryCode":191,"cosmosGeoPoint":209,"geoPoint":211,"contacts":30},"Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital","83301",{"type":57,"coordinates":210},[203,204],{"lat":204,"lon":203},{"type":213,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100600338","phase-1-study-of-gs-4321-in-healthy-participants-and-participants-with-chronic-hepatitis-delta-virus-100600338",false,"NCT07096193","Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus","Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta","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\u002Fm2 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 ) \\> 500 IU\u002FmL at screening.\n* Alanine aminotransferase (ALT) level \\> 1 × Upper limit of normal (ULN), but \\\u003C 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\u002FExclusion criteria may apply.",true,"ALL","18 Years","69 Years",{"count":226,"type":227},200,"ESTIMATED","INTERVENTIONAL",[230,231],"PHASE1","PHASE2","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.",[234],"Chronic Hepatitis Delta","2026-06-09",{"date":237,"type":238},"2026-06-11","ACTUAL",{"date":240,"type":238},"2025-07-31",{"date":242,"type":227},"2030-01",{"name":5,"class":6},19]