drugset / Trial / NCT00448253
Safety and Pharmacokinetic Study of Anthrax Immune Globulin Derived From Human Serum
Phase 1
Completed
92 enrolled
Emergent BioSolutions
Department of Health and Human Services · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the study is to assess the pharmacokinetics of three doses of NP-015 (210, 420 or 840 units TNA) in healthy volunteers. To evaluate the safety of NP-015 based on adverse events and laboratory assessments. To determine the dose proportionality relation of three different doses of NP-015.
Timeline
- Start
- 2007-07
- Primary completion
- 2008-08
- Completion
- 2008-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NP-015 | Protein / enzyme biologic | 210 iu | Intravenous |
| Subject | NP-015 | Protein / enzyme biologic | 420 iu | Intravenous |
| Subject | NP-015 | Protein / enzyme biologic | 840 iu | Intravenous |