Health Trials

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

ConditionChronic Hepatitis Delta
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-69
SponsorGilead Sciences

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

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.

Disqualifiers

Positive serum or urine pregnancy test.

Participants with plans to breastfeed during the study period.

Positive serum or urine pregnancy test.

Participants with plans to breastfeed during the study period.

Trial design

Design model

Sequential

Treatments tested in this trial

  • GS-4321

    Drug

    Administered subcutaneous (SC) or intravenously IV

  • GS-4321 Placebo

    Drug

    Administered SC

  • GS-4321

    Drug

    Administered SC

Treatment groups

200 Participants
are divided into 3 treatment groups
Group A: Phase 1: GS-4321Experimental treatment 1 intervention
Group B: Phase 1: PlaceboPlacebo comparator 1 intervention
Group C: Phase 2: GS-4321Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events

Time frame
Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up
2

Phase 1 and 2: Percentage of Participants With Treatment-emergent Serious Adverse Events

Time frame
Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up
3

Phase 1 and 2: Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities

Time frame
Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up
4

Phase 1: Serum Pharmacokinetic (PK) parameter; AUC of GS-4321

AUC is defined as the area under the concentration versus time curve

Time frame
First dose up to 24 Weeks

Secondary outcomes

1

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 .

Time frame
First dose up to 24 Weeks
2

Phase 2: Serum PK Parameters AUC of GS-4321

Time frame
Up to 96 weeks
3

Phase 2: Serum PK Parameters Cmax of GS-4321

Time frame
Up to 96 Weeks
4

Phase 2: Serum PK Parameters Tmax of GS-4321

Time frame
Up to 96 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gilead Sciences

Lead sponsor

Source ClinicalTrials.gov
Apply now