DSP-3025 Study of Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
Phase 1
Completed
- Conditions
- Allergic RhinitisHealthy Volunteer
- Interventions
- Drug: Placebo
- Registration Number
- NCT00925678
- Lead Sponsor
- Sumitomo Pharma Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 72
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 1 DSP-3025 - 2 Placebo -
- Primary Outcome Measures
Name Time Method Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
- Secondary Outcome Measures
Name Time Method Pharmacokinetics Nasal symptoms and peak nasal inspiratory flow Biomarkers nasal lavage and blood Clinical chemistry, haematology, urinalysis
Trial Locations
- Locations (1)
Kitasato University East Hospital
🇯🇵Sagamihara, Kanagawa, Japan