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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014