NCT00925678

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 22, 2009

Completed
Last Updated

April 12, 2022

Status Verified

April 1, 2022

First QC Date

June 19, 2009

Last Update Submit

April 9, 2022

Conditions

Allergic RhinitisHealthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry

Secondary Outcomes (4)

  • Clinical chemistry, haematology, urinalysis

  • Nasal symptoms and peak nasal inspiratory flow

  • Pharmacokinetics

  • Biomarkers nasal lavage and blood

Study Arms (2)

1

EXPERIMENTAL
Drug: DSP-3025

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DSP-3025DRUG
1
PlaceboDRUG
2

Eligibility Criteria

Age20 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kitasato University East Hospital

Sagamihara, Kanagawa, 228-8520, Japan

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2009

First Posted

June 22, 2009

Study Start

June 1, 2009

Last Updated

April 12, 2022

Record last verified: 2022-04

Locations

JP(1)