Safety and Tolerability Study of rBet v1 SLIT Tablets

PHASE1CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

November 30, 2007

Primary Completion Date

April 30, 2008

Study Completion Date

April 30, 2008

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

Trial Locations (1)

2100

National University Hospital - Allergy Unit 4222, Copenhagen

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

Stallergenes Greer

INDUSTRY