NCT00396149

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

A Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Higher Multi Dose Regimens to Subjects Sensitised to Birch Pollen

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Stallergenes Greer · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Birch Pollen-Related Rhinoconjunctivitis
• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
BIOLOGICAL	Placebo	Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
BIOLOGICAL	rBet v 1	Two tablets (1 placebo + 1 rBet v 1 or 2 rBet v 1) were administered every day over 2 weeks with a 2-day break for the week-end. Administered doses ranged from 50 to 300 µg rBet v 1.

Timeline

• Start date: 2006-11-01
• Primary completion: 2007-03-01
• Completion: 2007-06-01
• First posted: 2006-11-06
• Last updated: 2013-06-27

Locations

1 site across 1 country: Denmark