Study Evaluating Safety of Ragweed Mix Given by Intralymphatic Node Injections

Woodmont Pharmaceuticals

Status and phase

Terminated

Phase 1

Conditions

Allergic Rhinitis

Allergic Conjunctivitis

Treatments

Biological: Dose Level 1

Biological: Placebo

Biological: Dose Level 2

Study type

Interventional

Funder types

Industry

Identifiers

NCT03038971

16-290-0010

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

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