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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
55
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.
Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.
National University Hospital - Allergy Unit 4222
Copenhagen, Denmark
Local tolerability
Time frame: Assessed every day over 2 weeks
Global safety
Time frame: Assessed every day over 2 weeks
Immunological markers (IgE and IgG4)
Time frame: Between selection and follow-up visit (up to 18 weeks)
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