NCT00925678CompletedPhase 1
A Double-blind, Placebo-controlled, Randomised Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DSP-3025 Administered Intranasally to Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Sumitomo Pharma Co., Ltd.
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Double
Eligibility Criteria
- Ages
- 20 Years to 39 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
1
Experimental
Intervention: DSP-3025 (Drug)
2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
Secondary Outcomes
- Pharmacokinetics
- Clinical chemistry, haematology, urinalysis
- Nasal symptoms and peak nasal inspiratory flow
- Biomarkers nasal lavage and blood
Investigators
Study Sites (1)
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