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Clinical Trials/NCT01124396
NCT01124396CompletedNot Applicable

A Double-blind, Placebo-controlled, Randomised Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Repeated Weekly Doses of DSP-3025 Administered Intranasally to Healthy Male Volunteers

Sumitomo Pharma Co., Ltd.1 site in 1 country24 target enrollmentStarted: April 2010Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24
Locations
1
Primary Endpoint
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Investigate safety/tolerability after repeated weekly doses intranasal administration of DSP-3025 comparator placebo to healthy male volunteers

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 39 Years (Adult)
Sex
Male
Accepts 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

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 respiratory disorder(s) such as asthma

Arms & Interventions

30 ug

30 ug

Intervention: DSP-3025 (Drug)

60 ug

60 ug

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

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

Time Frame: During the study

Secondary Outcomes

  • Clinical chemistry, haematology, urinalysis, autoantibodies(During the study)
  • Nasal symptoms and peak nasal inspiratory flow(During the study)
  • Pharmacokinetics(During the study)
  • Biomarkers nasal lavage and blood(During the study)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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