DSP-3025 A Phase 1 Study of Healthy Male Volunteers
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
1 other identifier
observational
24
1 country
1
Brief Summary
Investigate safety/tolerability after repeated weekly doses intranasal administration of DSP-3025 comparator placebo to healthy male volunteers
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 13, 2010
CompletedFirst Posted
Study publicly available on registry
May 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedApril 12, 2022
April 1, 2022
4 months
May 13, 2010
April 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry
During the study
Secondary Outcomes (4)
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
Study Arms (3)
30 ug
30 ug
60 ug
60 ug
Placebo
Placebo
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg
- No clinically relevant abnormal findings
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kitasato University East Hospital
Asamizodai 2-1-1, Minami-ku, Sagamihara, Kanagawa, 252-0380, Japan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2010
First Posted
May 17, 2010
Study Start
April 1, 2010
Primary Completion
August 1, 2010
Study Completion
April 1, 2012
Last Updated
April 12, 2022
Record last verified: 2022-04