A Phase 1 interventional study of Single Ascending Dose (SAD) Cohorts GS-9620 and Multiple Ascending Dose (MAD) Cohorts GS-9620 in Hepatitis B, sponsored by Gilead Sciences. Completed at 20 sites in 5 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-12-20.
Sponsored by Gilead Sciences · Phase 1, Interventional, and Treatment
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 days 1-3 and/or days 8-10. Follow-up visits are required periodically through day 43. Subjects with sustained reductions in HbsAg will be requested to return for additional follow-up follow-up visits at 3 and 6 months post last dose. Study procedures involve blood draws for pharmacokinetic, pharmacodynamic, virologic, and safety assessments
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 51 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.
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Exclusion Criteria:
Drug: Single Ascending Dose (SAD) Cohorts GS-9620
Drug: Single Ascending Dose (SAD) Cohorts GS-9620
Drug: Single Ascending Dose (SAD) Cohorts GS-9620
Drug: Single Ascending Dose (SAD) Cohorts GS-9620
Drug: Multiple Ascending Dose (MAD) Cohorts GS-9620
Drug: Multiple Ascending Dose (MAD) Cohorts GS-9620
Drug: Multiple Ascending Dose (MAD) Cohorts GS-9620
Drug: Multiple Ascending Dose (MAD) Cohorts GS-9620
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
Assessment of adverse events in single and multiple oral doses of GS-9620
Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital signs measurements
Time frame: Periodically Day 1 to 6 months
Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods
SAD and MAD Cohorts:serial blood samples will be collected on Day 1 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48, and 96 hours post-dose. Mad Cohorts: serial blood samples will also be collected on Day 8 at 0 (pre-dose), , 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
Time frame: Day 1 and Day 8
Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs])
Single ascending dose (SAD) Cohorts: Whole blood and serum for pharmacodynamic (PD) assessments (RNA and cytokine analysis) will be drawn on Day 1 at pre-dose, 8, 24 and 48 hours post-dose, and on Days 5 and Day 8 Multiple ascending dose (MAD) Cohorts: Whole blood and serum for PD assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8 hours Postdose, Day 2, Day 3, and Day 5 Day 8: Pre-dose and 8 hours Post-dose, Day 9, 10, 12, and Day 15
Time frame: Days 1, 2, 3, 5, 8
Reduction of hepatitis B (HBV) viral load from baseline
SAD cohort: HBsAg+ levels will be drawn at Day 1: Pre-dose, Day 2, 3, 5, 8 and both Follow-up Visits. MAD cohorts: HBsAg+ levels will be drawn at Day 1: Pre-dose, Day 2, 3, 5, Day 8: Pre-Dose, 9, 10, 15, and both Follow-Up Visits.
Time frame: Screening, Baseline, Day 8 or 15
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Gilead Sciences