drugset
drugset / Trial / NCT00396149

Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1

NCT00396149 ↗

Phase 1 Completed 57 enrolled Stallergenes Greer Quintiles, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To investigate the safety and tolerability of successive single rising doses of SLIT in subjects with allergic rhinitis and to investigate the safety and tolerability of multi high dose regimens of SLIT in subjects with allergic rhinitis.

Timeline

Start
2006-11
Primary completion
2007-03
Completion
2007-06

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

EvaluationDrugModalityDoseRoute
Subject rBet v 1 Protein / enzyme biologic 50 ug Other
Subject rBet v 1 Protein / enzyme biologic 300 ug Other

Indications

seasonal allergic rhinitis