Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections
| Status: | Recruiting |
|---|---|
| Conditions: | Allergy, Ocular |
| Therapuetic Areas: | Ophthalmology, Otolaryngology |
| Healthy: | No |
| Age Range: | 16 - 65 |
| Updated: | 3/16/2017 |
| Start Date: | March 2017 |
| End Date: | June 2018 |
| Contact: | Caitlin Pearson |
| Email: | cpearson@oraclinical.com |
| Phone: | 978-685-8900 |
A Single-Center, Double-Blinded, Placebo-Controlled, Phase 1 Evaluation of the Safety of Ragweed Mix Given in Four Monthly Doses by Intralymphatic Node Injections for Inducing Tolerance in Subjects With Ragweed Induced Allergic Conjunctivitis and Allergic Rhinitis
A safety study conducted on subjects ≥16 years old evaluating the safety of 4 intralymphatic
injections of 2 different dose levels of the investigational short and tall ragweed product.
Biomarkers will be assessed at baseline and at multiple time points post-treatment.
injections of 2 different dose levels of the investigational short and tall ragweed product.
Biomarkers will be assessed at baseline and at multiple time points post-treatment.
Inclusion Criteria:
- Between the ages of 16 and 65 years old
- Seasonal Allergic Conjunctivitis (with or without Allergic Rhinitis) to ragweed
pollen
- Positive skin test reaction at screening visit to short ragweed extract
- Avoid disallowed medications
- Females of childbearing potential must have pregnancy test and must agree to use an
acceptable method of birth control
- Have blood and urine analysis within normal limits
- Manifest a positive reaction to a conjunctival allergen challenge with ragweed pollen
- Have a specific IgE ≥ 0.70 kU/L to short ragweed
Exclusion Criteria:
- Have ocular or nasal conditions that could affect subject safety or trial parameters
- Have a presence of an active sinus, nasal, or ocular infections
- Have had allergy immunotherapy to ragweed pollen
- Have a compromised lung function ≤80% of predicted
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