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A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple- Dose Ranging, Adaptive Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B Virus Infection
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 or days 1-3 and 8-10. Follow-up visits are also required periodically through day 43, and potential viral load follow-up visits at weeks 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic Hospital
Phoenix, Arizona, United States
West Coast Clinical Trials, LLC
Costa Mesa, California, United States
University of California Antiviral Research Center (AVRC)
San Diego, California, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, United States
Weill Cornell Medical College
New York, New York, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
Start Date
April 1, 2012
Primary Completion Date
September 1, 2013
Completion Date
October 1, 2013
Last Updated
November 14, 2013
49
ACTUAL participants
Single Ascending Dose (SAD) Cohorts GS-9620
DRUG
Multiple Ascending Dose (MAD) Cohorts
DRUG
Lead Sponsor
Gilead Sciences
NCT07024641
NCT06671093
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07275554