Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections

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.

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