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
| Registry | NCT05525650 |
|---|---|
| Status | Unknown |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 54 (Estimated) |
| Sponsor | RAPHAS (Industry) |
| Conditions | Mite Allergy, Rhinitis, Allergic, House Dust Mite Rhinitis |
| Interventions | House Dust Mite Extract, Dermatophagoides Farinae (Drug) |
| Dates | start 2022-01-20, primary completion 2024-12-21 (estimated), completion 2025-06-15 (estimated), first posted 2022-09-01, last updated 2024-04-10 |
| Locations | 1 site in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Mite Allergy All trials for Rhinitis, Allergic All trials of House Dust Mite Extract, Dermatophagoides Farinae
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 1Arm A | Experimental | Drug: House Dust Mite Extract, Dermatophagoides Farinae | As the maintenance UNIT, 200 PAU |
| 1Arm B | Placebo comparator | Drug: House Dust Mite Extract, Dermatophagoides Farinae | Placebo arm of 1Arm A. |
| 2Arm C | Experimental | Drug: House Dust Mite Extract, Dermatophagoides Farinae | As the maintenance UNIT, 400 PAU |
| 2Arm D | Placebo comparator | Drug: House Dust Mite Extract, Dermatophagoides Farinae | Placebo arm of 2Arm C. |
| 3Arm E | Experimental | Drug: House Dust Mite Extract, Dermatophagoides Farinae | As the maintenance UNIT, 800 PAU |
| 3Arm F | Placebo comparator | Drug: House Dust Mite Extract, Dermatophagoides Farinae | Placebo arm of 3Arm E. |
Sex: All, ages: 19 Years to 60 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |