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

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.

Inclusion Criteria:

• written consent
• Male or female subject from 18 to 60 years old and in general good health
• For woman of child bearing potential:
• Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
• Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) >0.70 kU/L at screening.
• FEV1 at least of 80% of predicted values at screening.
• Subject accepting to comply fully with the protocol.

Exclusion Criteria:

• Past or current disease which as judged by the Investigator, may affect the outcome of this study.
• History of life-threatening asthma,
• Asthma requiring daily treatment (whatever the pharmaceutical class).
• Pregnant or lactating woman.
• Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit.
• Subject who previously received desensitisation treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder) or who plan to start desensitisation treatment during this study.
• Symptoms during the treatment phase due to a sensitivity to a second allergen.
• Subjects treated with ongoing immunotherapy with another allergen