drugset / Trial / NCT01590641

A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B

NCT01590641

Phase 1 Completed 49 enrolled Gilead Sciences
RandomizedParallel-groupTriple-blindTreatment

Summary

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

Timeline

Start
2012-04
Primary completion
2013-09
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Vesatolimod Small molecule 0.3 mg
Subject Vesatolimod Small molecule 1 mg
Subject Vesatolimod Small molecule 2 mg
Subject Vesatolimod Small molecule 4 mg