Comparative Evaluation of Safety and Immune Activity of New Immunotherapeutic Agents for HDM Allergic Rhinitis Patients

A Randomized, Double Blind, Placebo-controlled, Multiple-dose, Parallel Phase Ⅰ Study to Evaluate Safety and Compare the Immune Stimulating Efficacy of "DF19001" in Dermatophagoides Farinae Sensitized Allergic Rhinitis Volunteers

When administering clinical trial drugs to patients with house dust mite allergic rhinitis, safety/tolerance is comparatively evaluated as the primary outcome, and symptom improvement and immune activity of the disease are comparatively evaluated as secondary outcome.

Inclusion Criteria:

• Patients aged 19 - 65years with allergic rhinitis caused by the house dust mite antigen.
• ImmunoCAP® titer > 3.49 kUA/L for the house dust mite antigen.
• Determined to be suitable for clinical trials as a result of laboratory tests.

Exclusion Criteria:

• Patients with uncontrolled, severe, or moderate asthma according to the Global Initiative for Asthma (GINA) guidelines.
• In case of lactation or pregnancy.
• If an infectious disease that may affect this study is identified.
• Patients with a history of rhinology surgery within 6 months prior to the first administration of the clinical investigational drug.
• If the allergy skin prick test is negative for the house dust mite antigen.