drugset / Trial / NCT00432770
Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.
Timeline
- Start
- 2006-12
- Primary completion
- —
- Completion
- 2007-03
Publications
- Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
- Gilbert JC, DeFeo-Fraulini T, Hutabarat RM, Horvath CJ, Merlino PG, Marsh HN, Healy JM, Boufakhreddine S, Holohan TV, Schaub RG. First-in-human evaluation of anti von Willebrand factor therapeutic aptamer ARC1779 in healthy volunteers. Circulation. 2007 Dec 4;116(23):2678-86. doi: 10.1161/CIRCULATIONAHA.107.724864. Epub 2007 Nov 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EGAPTIVON PEGOL | Aptamer | 0.05 mg/kg | Intravenous |
| Subject | EGAPTIVON PEGOL | Aptamer | 1 mg/kg | Intravenous |