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NCT00925678 Clinical Trial

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

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00925678
Other study ID # D7002013
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date June 2009

Study information
Verified date April 2022
Source Sumitomo Pharma Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 72
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 39 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• DSP-3025

• Placebo

Locations
Country Name City State
Japan Kitasato University East Hospital Sagamihara Kanagawa

Sponsors (1)
Lead Sponsor Collaborator
Sumitomo Pharma Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
Secondary Clinical chemistry, haematology, urinalysis
Secondary Nasal symptoms and peak nasal inspiratory flow
Secondary Pharmacokinetics
Secondary Biomarkers nasal lavage and blood
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