DSP-3025 Study of Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season

This study has been completed.
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
First received: June 19, 2009
Last updated: June 11, 2012
Last verified: June 2012
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.

Condition Intervention Phase
Allergic Rhinitis
Healthy Volunteer
Drug: DSP-3025
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Sumitomo Dainippon Pharma Co., Ltd.:

Primary Outcome Measures:
  • Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical chemistry, haematology, urinalysis [ Designated as safety issue: No ]
  • Nasal symptoms and peak nasal inspiratory flow [ Designated as safety issue: No ]
  • Pharmacokinetics [ Designated as safety issue: No ]
  • Biomarkers nasal lavage and blood [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: June 2009
Arms Assigned Interventions
Experimental: 1 Drug: DSP-3025
Placebo Comparator: 2 Drug: Placebo


Ages Eligible for Study:   20 Years to 39 Years
Genders Eligible for Study:   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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00925678

Kitasato University East Hospital
Sagamihara, Kanagawa, Japan, 228-8520
Sponsors and Collaborators
Sumitomo Dainippon Pharma Co., Ltd.
  More Information

Responsible Party: Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT00925678     History of Changes
Other Study ID Numbers: D7002013 
Study First Received: June 19, 2009
Last Updated: June 11, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 27, 2016