A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-4224 in Healthy Volunteers and Subjects with the Chronic Hepatitis B (CHB) Virus

Gilead Sciences, Inc0 sites210 target enrollmentDecember 4, 2018

ConditionsHepatitis B Infection - Other infectious diseases Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Hepatitis B
Sponsor: Gilead Sciences, Inc
Enrollment: 210
Status: Recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 4, 2018

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Gilead Sciences, Inc

Eligibility Criteria

Inclusion Criteria

•1\)Have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures
•2\)Be aged 18 through 45 years of age, inclusive at screening
•3\)Be a non\-smoker. The use of nicotine or nicotine\-containing products must be discontinued 90 days prior to the first dose of study drug
•4\)Have a calculated BMI of \>\=19 and \=\< 30 kg/m2 at screening
•5\)Have a creatinine clearance (CLcr) \>\= 90 mL/min (using the Cockcroft\-Gault method based on serum creatinine and actual body weight as measured at screening
•6\)Females of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at clinic admission (unless permanently sterile or greater than 2 years postmenopausal)
•7\)Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception.
•8\)Male subjects must refrain from sperm donation from clinic admission (eg, Day \-2 or Day \-1\), throughout the study period, and continuing for at least 90 days following the last dose of study drug
•9\)Female subjects must refrain from egg donation and in vitro fertilization during treatment and until at least 30 days after the end of relevant systemic exposure
•10\)Subjects have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug.

Exclusion Criteria

•1\)Be a lactating female
•2\)Have received any study drug within 30 days prior to study dosing
•3\)Have current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance or subject safety
•4\)Have a positive test result for HIV, HBsAg, or HCV antibody
•a)Subjects who are HCV Ab positive, but have a documented negative HCV RNA, are eligible
•5\)Have a positive test result for autoantibodies (ANA \>1:80 and/or anti\-SMA \>1:80 and/or AMA\>1:40 and/or anti\-TPO \>1:40\)
•6\)Have poor venous access that limits phlebotomy
•7\)Have taken any prescription medications or over\-the\-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins and/or acetaminophen and/or ibuprofen and/or hormonal contraceptive medications.
•8\)Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, and other immune\- or cytokine\-based therapies)
•9\)Have a history of any of the following: