Comparative Evaluation of Safety and Immune Activity of New Immunotherapeutic Agents for HDM Alle… (NCT05525650) | Clinical Trial Compass
UnknownPhase 1
Comparative Evaluation of Safety and Immune Activity of New Immunotherapeutic Agents for HDM Allergic Rhinitis Patients
South Korea54 participantsStarted 2022-01-20
Plain-language summary
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.
Who can participate
Age range19 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Vital signs
Timeframe: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
2
Health examination
Timeframe: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
3
laboratory test
Timeframe: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
4
laboratory test
Timeframe: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
5
laboratory test
Timeframe: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
6
Electrocardiography
Timeframe: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
7
Local Adverse Event
Timeframe: 1 day before dosing, Post-study visit(within 15 days after clinical completion)