[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-hepatitis-delta\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-hepatitis-delta":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"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":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25,26],"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.",[29],"Chronic Hepatitis Delta","RECRUITING","2026-06-09",{"date":33,"type":34},"2026-06-11","ACTUAL",{"date":36,"type":34},"2025-07-31",{"date":38,"type":22},"2030-01",{"name":40,"class":41},"Gilead Sciences","INDUSTRY",19]