drugset / Trial / NCT03453060
Safety and Tolerability Study of E-WE Thrombin in Healthy Adult Subjects
RandomizedSequentialQuadruple-blindTreatment
Summary
The purpose of this study is to assess the safety, tolerability and pharmacodynamics of a single iv dose of E-WE Thrombin in healthy adult subjects.
Timeline
- Start
- 2018-05-30
- Primary completion
- 2018-11-25
- Completion
- 2018-11-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | E-WE Thrombin | Protein / enzyme biologic | 0.5 ug/kg | Intravenous |
| Subject | E-WE Thrombin | Protein / enzyme biologic | 1 ug/kg | Intravenous |
| Subject | E-WE Thrombin | Protein / enzyme biologic | 2 ug/kg | Intravenous |
| Subject | E-WE Thrombin | Protein / enzyme biologic | 4 ug/kg | Intravenous |