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DSP-3025 A Phase 1 Study of Healthy Male Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01124396
First Posted: May 17, 2010
Last Update Posted: January 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sumitomo Dainippon Pharma Co., Ltd.
  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 Sumitomo Dainippon Pharma Co., Ltd.:

Primary Outcome Measures:
  • Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry [ Time Frame: During the study ]

Secondary Outcome Measures:
  • Clinical chemistry, haematology, urinalysis, autoantibodies [ Time Frame: During the study ]
  • Nasal symptoms and peak nasal inspiratory flow [ Time Frame: During the study ]
  • Pharmacokinetics [ Time Frame: During the study ]
  • Biomarkers nasal lavage and blood [ Time Frame: During the study ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124396


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

Responsible Party: Sumitomo Dainippon Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01124396     History of Changes
Other Study ID Numbers: D7002027
First Submitted: May 13, 2010
First Posted: May 17, 2010
Last Update Posted: January 8, 2014
Last Verified: January 2014