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Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus
Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus

NCT07096193

RecruitingPhase 1, Phase 2

Sponsor: Gilead Sciences

Conditions: Chronic Hepatitis Delta

Interventions: GS-4321, GS-4321 Placebo, GS-4321

Countries: United States, Bulgaria, Germany, Italy, Moldova, Romania, South Korea, Taiwan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 69 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

Part A:

* 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.
* Have a body mass index (BMI) of ≤ 30.0 kg/m2 at screening and at admission.

Part B:

* 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.
* Chronic hepatitis delta (CHD) for ≥ 6 months prior to screening, documented by prior medical history.
* 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.
* Non-cirrhotic or compensated cirrhosis.
* Hepatitis delta virus ribonucleic acid (HDV RNA ) \> 500 IU/mL at screening.
* Alanine aminotransferase (ALT) level \> 1 × Upper limit of normal (ULN), but \< 10 × ULN at screening.

Key Exclusion Criteria:

Part A:

* Positive serum or urine pregnancy test.
* Participants with plans to breastfeed during the study period.

Part B:

* Positive serum or urine pregnancy test.
* Participants with plans to breastfeed during the study period.
* Current or previous clinically decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage due to HDV or HBV.
* Child-Turcotte-Pugh (CTP)-B or -C or a CTP score of ≥ 7.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations (22)
  • Anaheim, California, United States
  • Louisville, Kentucky, United States
  • Baltimore, Maryland, United States
  • New York, New York, United States
  • Sofia, Bulgaria
  • Hanover, Germany
  • Milan, Italy
  • Chinsinau, Moldova
  • Chisinau, Moldova
  • Chisinau, Moldova
  • Bucharest, Romania
  • Bucharest, Romania
  • Bucharest, Romania
  • Iași, Romania
  • Ansan-si, South Korea
  • Bucheon-si, South Korea
  • Seoul, South Korea
  • Seoul, South Korea
  • Chiayi City, Taiwan
  • Kaohsiung City, Taiwan
  • Kaohsiung City, Taiwan
  • Taipei, Taiwan