DSP-3025 A Phase 1 Study of Healthy Male Volunteers

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01124396
• Other study ID #: D7002027
• Status: Completed
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2022
• Source: Sumitomo Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2012
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• DSP-3025

• Placebo

Locations

Country	Name	City	State
Japan	Kitasato University East Hospital	Asamizodai 2-1-1, Minami-ku, Sagamihara	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry		During the study
Secondary	Clinical chemistry, haematology, urinalysis, autoantibodies		During the study
Secondary	Nasal symptoms and peak nasal inspiratory flow		During the study
Secondary	Pharmacokinetics		During the study
Secondary	Biomarkers nasal lavage and blood		During the study