drugset / Trial / NCT00517855
Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of PRTX-100 in Healthy Adult Volunteers
RandomizedSingle-groupDouble-blindTreatment
Summary
This study is the second human clinical study with PRTX-100. It is designed to assess the safety of a single intravenous (IV) dose of PRTX-100, as well as, how the drug is eliminated from the blood after dosing. Additionally, this study provides an opportunity to monitor immune system response to PRTX-100.
Timeline
- Start
- 2007-06
- Primary completion
- 2007-09
- Completion
- 2007-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BEVIFIMOD | Protein / enzyme biologic | 0.3 ug/kg | Intravenous |
| Subject | BEVIFIMOD | Protein / enzyme biologic | 0.45 ug/kg | Intravenous |
Indications
No indication recorded.