Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522729-36 | Other Identifier | EU CT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
The 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.
The 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1: GS-4321 | Experimental | Participants will receive single escalating doses of GS-4321. |
|
| Phase 1: Placebo | Placebo Comparator | Participants will receive placebo to match the single escalating doses of GS-4321 |
|
| Phase 2: GS-4321 | Experimental | Participants will receive multiple escalating doses of GS-4321 up to 96 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-4321 | Drug | Administered subcutaneous (SC) or intravenously IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events | Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up | |
| Phase 1 and 2: Percentage of Participants With Treatment-emergent Serious Adverse Events | Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up | |
| Phase 1 and 2: Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities | Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up | |
| Phase 1: Serum Pharmacokinetic (PK) parameter; AUC of GS-4321 | AUC is defined as the area under the concentration versus time curve | First dose up to 24 Weeks |
| Phase 1: Serum PK Parameter: Cmax | Cmax is defined as the maximum observed concentration of drug. | First dose up to 24 Weeks |
| Phase 1: Serum PK Parameter: Tmax | Tmax is defined as the time (observed time point) of Cmax. | First dose up to 24 Weeks |
| Phase 1: Serum PK Parameter: t1/2 | First dose up to 24 Weeks | |
| Phase 2: Proportion of Participants with Combined Response | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1: Proportion of Participants who Develop Antidrug Antibody (ADAs) After Administration of a Single Dose of GS-4321 and ADA Titer Characterization | ADA Titer characterization will include proportion of participants with ADA incidence, prevalence, persistence, and transience . | First dose up to 24 Weeks |
Not provided
Key Inclusion Criteria:
Part A:
Part B:
Key Exclusion Criteria:
Part A:
Part B:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Contact | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Recruiting | Anaheim | California | 92801 | United States | |
| University of Louisville, Clinical Trials Unit |
Not provided
| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| GS-4321 Placebo |
| Drug |
Administered SC |
|
| GS-4321 | Drug | Administered SC |
|
| Up to 96 Weeks |
| Phase 2: Serum PK Parameters AUC of GS-4321 |
| Up to 96 weeks |
| Phase 2: Serum PK Parameters Cmax of GS-4321 | Up to 96 Weeks |
| Phase 2: Serum PK Parameters Tmax of GS-4321 | Up to 96 Weeks |
| Phase 2: Serum PK Parameters Ctrough of GS-4321 | Up to 96 Weeks |
| Phase 2: Proportion of Participants With Undetectable HDV RNA or ≥ 2 log10 Decrease in HDV RNA From Baseline and normal ALT (ALT < ULN). | Weeks 4, 8, 12, 16, 20, 36, 48, 60, 72, 84, and 96 |
| Phase 2: Change From Baseline in HDV RNA | Baseline, Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96 |
| Phase 2: Proportion of Participants With Undetectable HDV RNA | Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96 |
| Proportion of Participants With undetectable HDV RNA or ≥ 2 log10 Decrease in HDV From Baseline | Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84 and 96 |
| Phase 2: Change From Baseline in Liver Stiffness by Elastography | Weeks 24, 48, and 96 |
| Phase 2: Proportion of Participants with normal ALT | Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96 |
| Phase 2: Proportion of Participants who Develop ADAs After Administration of Multiple Doses of GS-4321 and ADA Titer Characterization | ADA Titer characterization will include proportion of participants with ADA incidence, prevalence, persistence, and transience . | First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up |
| Phase 2: Characterize if Emergent Variants are Associated With Reduced Susceptibility to GS-4321 in Vitro and Virologic Failure in Participants With CHD | First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up |
| Recruiting |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| University of Maryland, Institute of Human Virology, Clinical Research Unit | Recruiting | Baltimore | Maryland | 21201 | United States |
| The New York-Presbyterian Hospital | Recruiting | New York | New York | 10021 | United States |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, SC Gastroenterologia ed Epatologia | Recruiting | Milan | 882 | Italy |
| IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba" | Recruiting | Chinsinau | 2004 | Moldova |
| IMSP Spitalul Clinic de Boli Infectioase "Toma Ciorba" | Recruiting | Chisinau | 2004 | Moldova |
| PMSI Clinical Republican Hospital "Timofei Mosneaga" | Recruiting | Chisinau | MD-2025 | Moldova |
| Institutul National De Boli Infectioase Prof. Dr. Matei Bals | Recruiting | Bucharest | 021105 | Romania |
| Fundatia Dr. Victor Babes | Recruiting | Bucharest | 030303 | Romania |
| Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals | Recruiting | Bucharest | 21105 | Romania |
| Gastromedica S.R.L. | Recruiting | Iași | 700506 | Romania |
| Korea University Ansan Hospital | Recruiting | Ansan-si | 425-707 | South Korea |
| The Catholic University of Korea Bucheon St. Mary's Hospital | Recruiting | Bucheon-si | 14647 | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Recruiting | Seoul | 06591 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 135-710 | South Korea |
| Ditmanson Medical Foundation Chia-Yi Christian Hospital | Recruiting | Chiayi City | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Recruiting | Kaohsiung City | 807 | Taiwan |
| Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital | Recruiting | Kaohsiung City | 83301 | Taiwan |
| ID | Term |
|---|---|
| D019701 | Hepatitis D, Chronic |
| ID | Term |
|---|---|
| D003699 | Hepatitis D |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided