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

This study is ongoing, but not recruiting participants.

First Received on June 19, 2009. Last Updated on August 8, 2010 History of Changes

Sponsor:	Dainippon Sumitomo Pharma
Information provided by:	Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier:	NCT00925678

Purpose

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:

MedlinePlus related topics: Hay Fever

U.S. FDA Resources

Further study details as provided by Dainippon Sumitomo Pharma:

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

Eligibility

Ages Eligible for Study:	20 Years to 39 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00925678

Locations

Japan
Kitasato University East Hospital
2-1-1, Asamizodai, Sagamihara, Kanagawa, Japan, 228-8520

Sponsors and Collaborators

Dainippon Sumitomo Pharma

More Information

No publications provided

Responsible Party:	Public Relations, Dainippon Sumitomo Pharma Co., Ltd
ClinicalTrials.gov Identifier:	NCT00925678 History of Changes
Other Study ID Numbers:	D7002013
Study First Received:	June 19, 2009
Last Updated:	August 8, 2010
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity

Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on May 23, 2012