NCT00396149CompletedPhase 1
A Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Higher Multi Dose Regimens to Subjects Sensitised to Birch Pollen
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Stallergenes Greer
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Local tolerability
Study Overview
Brief Summary
To investigate the safety and tolerability of successive single rising doses of SLIT in subjects with allergic rhinitis and to investigate the safety and tolerability of multi high dose regimens of SLIT in subjects with allergic rhinitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •written consent
- •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) of at least Class 2 at screening.
- •FEV1 at least of 80% of predicted values at screening.
Exclusion Criteria
- •Patient who previously received desensitization treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder...) or who plan to start desensitization treatment during this study.
Outcomes
Primary Outcomes
Local tolerability
Time Frame: Assessed every day over 2 weeks
Global safety
Time Frame: Assessed every day over 2 weeks
Secondary Outcomes
- Immunological markers (IgE and IgG4)(Between selection and follow-up visit)
Investigators
Study Sites (1)
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