Text Size

DSP-3025 A Phase 1 Study of Healthy Male Volunteers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Dainippon Sumitomo Pharma.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Dainippon Sumitomo Pharma
ClinicalTrials.gov Identifier:
NCT01124396
First received: May 13, 2010
Last updated: February 22, 2012
Last verified: August 2010
History of Changes
  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: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
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 ]

Estimated Enrollment: 24
Study Start Date: April 2010
Arms Assigned Interventions
Experimental: 1 Drug: DSP-3025
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 39 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 Company, Ltd.
ClinicalTrials.gov Identifier: NCT01124396     History of Changes
Other Study ID Numbers: D7002027
Study First Received: May 13, 2010
Last Updated: February 22, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on May 21, 2013