Safety and Tolerability Study of Ragweed 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 ragweed pollen allergen extract administered as sublingual tablets in subjects with allergic rhinitis to ragweed.

Official Title
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Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy Tablets Given in Single Rising Doses and in Multi Dose Regimens to Subjects With an Allergy to Ragweed Pollen.

Conditions
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Rhinitis, Allergic, Seasonal, Ragweed Pollen Allergy

Intervention / Treatment
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* Drug: Sublingual tablet of ragweed pollen allergen extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written consent male or female subjects from 18 yo 60 years old and in general good health for women of child bearing potential: negative urine pregnancy test and use of medically effective contraceptive method symptoms of ragweed pollen induced allergic rhinitis for at least the last 2 years sensitization to ragweed pollen as demonstrated with positive skin prick test to ragweed pollen and specific IgE level (ragweed pollen) > 0.70 kU/l at screening FEV1 at least of 80% of predicted value at screening 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 women subjects who previously received desensitisation treatment to ragweed pollen and/or other Asteraceae 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: Sublingual tablet of ragweed pollen allergen extract<br>* administered once a day over 10 days<br>|
| Experimental: 2<br> | Drug: Sublingual tablet of ragweed pollen allergen extract<br>* administered once a day over 10 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological markers (IgE and IgG4) |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ragweed, allergy, sublingual immunotherapy