Status:
COMPLETED
DSP-3025 Study of Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
Lead Sponsor:
Sumitomo Pharma Co., Ltd.
Conditions:
Allergic Rhinitis
Healthy Volunteer
Eligibility:
MALE
20-39 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg
- No clinically relevant abnormal findings
- History of cedar and/or Japanese cypress pollen induced seasonal allergic rhinitis for at least the previous 2 years (only Allergic rhinitis)
Exclusion
- Acute illness which requires medical intervention
- Definite or suspected personal history of adverse drug reactions or drug hypersensitivity
- Clinical relevant disease or disorder (past or present)
- A history of asthma
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT00925678
Start Date
June 1 2009
Last Update
April 12 2022
Active Locations (1)
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1
Kitasato University East Hospital
Sagamihara, Kanagawa, Japan, 228-8520