Safety and Tolerance Study of Grass Pollen-derived Peptides to Treat Allergic Rhinitis
Phase 1
Completed
- Conditions
- Seasonal Allergic Rhinoconjunctivitis
- Interventions
- Biological: gpASIT+TM
- Registration Number
- NCT00813046
- Lead Sponsor
- BioTech Tools S.A.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description gpASIT+TM gpASIT+TM -
- Primary Outcome Measures
Name Time Method To demonstrate the clinical tolerability and safety of the treatment by looking at the absence of immediate allergic reaction. 10 days
- Secondary Outcome Measures
Name Time Method vital signs clinical laboratory evaluations adverse events general physical status 10 days
Trial Locations
- Locations (1)
Hospital University Ghent
🇧🇪Ghent, Belgium