Safety and Tolerability Study of rBet v1 SLIT Tablets

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Birch Pollen-Related Rhinoconjunctivitis, Rhinitis, Allergic, Seasonal

Intervention / Treatment
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* Biological: rBet v 1
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo group | Biological: Placebo<br>* Two matching placebo tablets were administered every day over 2 weeks with a 2-day break for the week-end.<br>|
| Experimental: 2<br>rBet v 1 tablets | Biological: rBet v 1<br>* 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.<br>* Other names: rBet v 1.0101;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tolerability |  | Assessed every day over 2 weeks | 
| Global safety |  | Assessed every day over 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological markers (IgE and IgG4) |  | Between selection and follow-up visit (up to 18 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rBet v 1, Birch pollen allergy, Sublingual Immunotherapy