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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: DSP-3025

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Japan
  • Kanagawa
    • Asamizodai 2-1-1, Minami-ku, Sagamihara, Kanagawa, Japan, 252-0380
      • Kitasato University East Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
30 ug	Drug: DSP-3025
60 ug	Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry	During the study

Secondary Outcome Measures

Outcome Measure	Time Frame
Nasal symptoms and peak nasal inspiratory flow	During the study
Pharmacokinetics	During the study
Biomarkers nasal lavage and blood	During the study
Clinical chemistry, haematology, urinalysis, autoantibodies	During the study

Collaborators and Investigators

• Sponsor: Sumitomo Pharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: May 13, 2010
• First Submitted That Met QC Criteria: May 13, 2010
• First Posted (Estimate): May 17, 2010

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 9, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: D7002027