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Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus.
EU CTIS ID: 2025-522729-36-00
What this study is testing
Part A Objectives: To evaluate the safety and tolerability of escalating single doses of GS-4321 administered in healthy participants. To evaluate the pharmacokinetics (PK) of a single dose of GS-4321 following subcutaneous (SC) and intravenous (IV) administration. Part B Objectives: To evaluate the efficacy of GS-4321 in participants with chronic hepatitis delta infection (CHD) To evaluate the safety and tolerability of escalating multiple doses of GS-4321 administered in participants with CHD
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Part A: Participants 18 years of age to < 70 years at screening, able to understand and give written informed consent and comply with treatment and follow-up.
- Part B: Participants 18 years of age to < 70 years at screening, able to understand and give written informed consent and comply with treatment and follow-up.
- 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.
- 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.
- Part A: Must, in the opinion of the investigator, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, and screening laboratory evaluations.
- Part A: Have a body mass index (BMI) of ≤ 30.0 kg/m2 at screening and at admission.
You likely can't join if
- 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.
See the full eligibility criteria
- Part A: Participants 18 years of age to < 70 years at screening, able to understand and give written informed consent and comply with treatment and follow-up.
- Part B: Participants 18 years of age to < 70 years at screening, able to understand and give written informed consent and comply with treatment and follow-up.
- 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.
- 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.
- Part A: Must, in the opinion of the investigator, be sufficiently healthy for study participation based upon medical history, physical examination, vital signs, and screening laboratory evaluations.
- Part A: Have a body mass index (BMI) of ≤ 30.0 kg/m2 at screening and at admission.
- Part B: CHD for ≥ 6 months prior to screening, documented by prior medical history.
- Part B: Must be receiving commercially available entecavir, tenofovir alafenamide, or tenofovir disoproxil fumarate at or prior to enrollment. Coformulation as part of a fixed-dose combination for the treatment of HIV is permitted.
- Part B: Noncirrhotic or compensated cirrhotic liver disease as defined below: 1. Noncirrhotic as defined by liver stiffness (as measured by elastography, eg, FibroScan®) < 12.5 kPa within the 6 months prior to or at screening 2. Compensated cirrhotic as defined by meeting all criteria below: a. Liver stiffness (as measured by elastography, eg, FibroScan) ≥ 12.5 within the 6 months prior to or at screening b. Child-Turcotte-Pugh (CTP) score of < 7 at screening
- Part B: HDV RNA > 500 IU/mL at screening.
- Part B: ALT level > 1 × ULN, but < 10 × ULN at screening (Cohorts B1, B2, and B3) or ALT < 10 × ULN at screening (Cohort B4, ≤ ULN, with sponsor approval).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
- Taiwan
- Korea, Republic of
- Moldova, Republic of
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey; Taiwan; Korea, Republic of; Moldova, Republic of; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.