Tolerability of ALK Tree Tablet

A Randomised, Multiple Dose, Dose Escalation, Double-Blind, Placebo-Controlled Phase I Study Investigating the Safety of ALK Tree Tablet in Adult Subjects With Birch Pollen Induced Rhinoconjunctivitis (With/Without Asthma).

This trial is performed to assess the tolerability of the ALK Tree Tablet in patients with birch pollen induced allergy

Inclusion Criteria:

• A clinical history of birch pollen induced rhinoconjunctivitis (with or without mild to moderate asthma ) of at least two years prior to trial entry requiring symptomatic treatment during the birch pollen season.
• Positive Skin Prick Test response to Betula verrucosa
• Positive specific IgE against Bet v1
• FEV1 ≥ 70% of predicted value

Exclusion Criteria:

• No clinical history of perennial allergic rhinitis and/or asthma caused by an allergen to which the subject is regularly exposed and sensitised
• No clinical history of significant recurrent acute sinusitis (defined as 2 episodes per year for the last two years all of which required antibiotic treatment) or chronic sinusitis
• No conjunctivitis, rhinitis or asthma at the screening or randomisation visit
• No history of anaphylaxis, including anaphylactic food allergy, bee venom anaphylaxis, exercise anaphylaxis or drug induced anaphylaxis
• No history of angioedema