drugset / Trial / NCT01590641
A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis B
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
| 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 | — |