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

PHASE1CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

November 30, 2006

Primary Completion Date

March 31, 2007

Study Completion Date

June 30, 2007

Conditions
Birch Pollen-Related RhinoconjunctivitisRhinitis, Allergic, Seasonal
Interventions
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.

Trial Locations (1)

Unknown

National University Hospital - Allergy Unit 4222, Copenhagen

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

Stallergenes Greer

INDUSTRY