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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00925678

Enrollment

Registered

2009-06-22

Start date

2009-06-30

Completion date

Unknown

Last updated

2022-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Healthy Volunteer

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.

Interventions

DRUGDSP-3025

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

20 Years to 39 Years

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

Design outcomes

Primary

Measure	Time frame
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry	—

Secondary

Measure	Time frame
Clinical chemistry, haematology, urinalysis	—
Nasal symptoms and peak nasal inspiratory flow	—
Pharmacokinetics	—
Biomarkers nasal lavage and blood	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026