NCT00889460

Safety and Tolerability Study of rBet v1 SLIT Tablets

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Stallergenes Greer · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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 12.5 to 100 µg rBet v 1.
BIOLOGICAL	Placebo	Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2009-04-29
• Last updated: 2009-04-29

Locations

1 site across 1 country: Denmark