DSP-3025 A Phase 1 Study of Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier:
NCT01124396
First received: May 13, 2010
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Healthy
Drug: DSP-3025
Drug: Placebo
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Dainippon Sumitomo Pharma:

Primary Outcome Measures:
  • Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry [ Time Frame: During the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical chemistry, haematology, urinalysis, autoantibodies [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Nasal symptoms and peak nasal inspiratory flow [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: During the study ] [ Designated as safety issue: No ]
  • Biomarkers nasal lavage and blood [ Time Frame: During the study ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2010
Study Completion Date: April 2012
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
30 ug
30 ug
Drug: DSP-3025
60 ug
60 ug
Drug: Placebo
Placebo
Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 39 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

no

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124396

Locations
Japan
Kitasato University East Hospital
Asamizodai 2-1-1, Minami-ku, Sagamihara, Kanagawa, Japan, 252-0380
Sponsors and Collaborators
Dainippon Sumitomo Pharma
  More Information

No publications provided

Responsible Party: Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier: NCT01124396     History of Changes
Other Study ID Numbers: D7002027
Study First Received: May 13, 2010
Last Updated: January 7, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on April 17, 2014