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

Description

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 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.

Conditions

Chronic Hepatitis Delta
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Related Conditions:

Chronic Hepatitis Delta

Study Overview

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Study Details

Study overview

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 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.

Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta

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

Condition
Chronic Hepatitis Delta
Intervention / Treatment

-

Contacts and Locations

Anaheim

Investigative Site, Anaheim, California, United States, 92801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Must be receiving a commercially available nucleoside/nucleotide analogue for the treatment of hepatitis B virus (HBV) infection at enrollment.
  • * Hepatitis delta virus ribonucleic acid (HDV RNA ) \> 100 IU/mL at screening.
  • * Alanine aminotransferase (ALT) level \> 1 × Upper limit of normal (ULN), but \< 10 × ULN at screening.
  • * 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.
  • * 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.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2028-12