Safety and Tolerance Study of Grass Pollen-derived Peptides to Treat Allergic Rhinitis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether the oral administration of grass pollen peptides to treat allergic rhinitis is safe and well tolerated.

Official Title
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Preliminary Assessment of the Short Term Clinical Tolerability and Safety of Grass Pollen-derived Peptides for Oral Use in Antigen-specific Immunotherapy of Seasonal Allergic Rhinoconjunctivitis

Conditions
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Seasonal Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Biological: gpASIT+TM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 50 years The subjects are in good physical and mental health according to his/her medical history, vital signs, and clinical status Male or non-pregnant, non-lactating females A history of seasonal allergic rhinoconjunctivitis (SAR) during the grass pollen season during at least the last two years A positive skin prick test to grass-pollen mixture Specific IgE against grass pollen (RAST class 2 or IgE > 0.7 kU/l) Asymptomatic to perennial inhalant allergens Exclusion Criteria: Subjects with current or past immunotherapy for SAR Subjects requiring controller medication against asthma (bronchodilator nebulised drugs or local or systemic corticosteroids) Documented evidence of acute or significant chronic sinusitis (as determined by individual investigator) Subjects with a history of food allergy and consecutive anaphylaxis Subjects with a history of hepatic or renal disease Subject with malignant disease, autoimmune disease Female subjects who are pregnant, lactating, or of child-bearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD). Females unable to bear children must have documentation of such (i.e. tubal ligation, hysterectomy, or post menopausal [defined as a minimum of one year since the last menstrual period]) Any chronic disease, which may impair the subject's ability to participate in the trial (i.e. severe congestive heart failure, active gastric or duodenal ulcer, uncontrolled diabetes mellitus, etc…) Subjects with clinically relevant abnormal QTc intervals of the ECG : QTc > 450 ms for man and > 470 ms for women Subjects requiring beta-blockers medication Chronic use of concomitant medications that would affect assessment of the effectiveness of the study medication (e.g. tricyclic antidepressants) Subject with febrile illness (> 37.5°C, oral) A known positive serology for HIV-1/2, HBs antigen or anti-HCV antibodies The subject is immunocompromised by medication or illness, has received a vaccine, corticoids or immunosuppressive medications within 1 month before study entry Receipt of blood or a blood derivative in the past 6 months preceding study entry Regular consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 4 weeks preceding the study, any consumption of corticoids (oral, topic or nasal) or of anti-histaminic drugs within 1 week preceding the study Use of long-acting antihistamines Any condition which could be incompatible with protocol understanding and compliance Subjects who have forfeited their freedom by administrative or legal award or who are under guardianship, Participation in another clinical trial and/or treatment with an experimental drug within 1 month of study start A history of hypersensitivity to the excipients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gpASIT+TM<br> | Biological: gpASIT+TM<br>* oral administration of entero-coated capsules containing increasing doses of gpASIT+TM (25 to 1600µg), one dose per day for 4 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate the clinical tolerability and safety of the treatment by looking at the absence of immediate allergic reaction. |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital signs clinical laboratory evaluations adverse events general physical status |  | 10 days |