Safety and Tolerability Study of Ragweed SLIT Tablets
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.
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 13, 2010
CompletedFirst Posted
Study publicly available on registry
October 20, 2010
CompletedNovember 8, 2010
October 1, 2010
3 months
October 13, 2010
November 5, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks
2 weeks
Secondary Outcomes (1)
Immunological markers (IgE and IgG4)
2 weeks
Study Arms (2)
1
PLACEBO COMPARATOR2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stallergenes Greerlead
- Quintiles, Inc.collaborator
Study Sites (1)
DRC Drug Research Center
Balatonfüred, H-8230, Hungary
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eva Péterfai, MD
DRC Drug Research Center, Balatonfüred - Hungary
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 13, 2010
First Posted
October 20, 2010
Study Start
January 1, 2009
Primary Completion
April 1, 2009
Study Completion
October 1, 2009
Last Updated
November 8, 2010
Record last verified: 2010-10