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

NCT ID: NCT00925678

Last Updated: 2022-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Brief Summary

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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

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Conditions

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Allergic Rhinitis Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Blinding Strategy

DOUBLE

Study Groups

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1

Group Type EXPERIMENTAL

DSP-3025

Intervention Type DRUG

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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DSP-3025

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sumitomo Pharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kitasato University East Hospital

Sagamihara, Kanagawa, Japan

Site Status

Countries

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Japan

Other Identifiers

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D7002013

Identifier Type: -

Identifier Source: org_study_id

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