drugset / Trial / NCT00889460
Safety and Tolerability Study of rBet v1 SLIT Tablets
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.
Timeline
- Start
- 2007-11
- Primary completion
- 2008-04
- Completion
- 2008-04
Publications
- Results L. Winther, L.K. Poulsen, B. Robin, M. Mélac, H. Malling Safety and Tolerability of Recombinant Bet v 1 (rBet v 1) Tablets in Sublingual Immunotherapy (SLIT) The Journal of Allergy and Clinical Immunology February 2009 (Vol. 123, Issue 2, Page S215)
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rBet v 1 | Protein / enzyme biologic | 12.5 ug | Other |
| Subject | rBet v 1 | Protein / enzyme biologic | 100 ug | Other |