drugset / Trial / NCT01590654
A Study Evaluating GS-9620 in Virologically Suppressed Subjects With Chronic Hepatitis B Virus Infection
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 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
Timeline
- Start
- 2012-04
- Primary completion
- 2013-11
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |