drugset / Trial / NCT01405833
Study of the Safety, Tolerability, Pharmacokinetics and Safety of BG00010 (Neublastin) in Subjects With Sciatica.
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetic (PK) profile of 3 intravenous (IV) injections of BG00010 given on 2 fixed schedules; weekly and as frequently as every 48 hours (but no more than 3 times per week). Secondary objectives of this study in this study population are to explore the repeated-dose immunogenicity of BG00010 and to explore the potential of BG00010 to reduce pain following multiple-dose administration.
Timeline
- Start
- 2011-07
- Primary completion
- 2012-09
- Completion
- 2012-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | artemin | Protein / enzyme biologic | — | Intravenous |