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Investigate safety/tolerability after a single dose intranasal administration of DSP-3025 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DSP-3025 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical chemistry, haematology, urinalysis | ||
| Nasal symptoms and peak nasal inspiratory flow | ||
| Pharmacokinetics |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kitasato University East Hospital | Sagamihara | Kanagawa | 228-8520 | Japan |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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|
| Biomarkers nasal lavage and blood |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |