DSP-3025 A Phase 1 Study of Healthy Male Volunteers

Completed

• Conditions: Healthy
• Interventions: Drug: DSP-3025; Drug: Placebo

• Registration Number: NCT01124396
• Lead Sponsor: Sumitomo Pharma Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-13
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-17
• Primary Completion: 2010-08
• Study Completion: 2012-04
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-09
• Last Update Posted: 2022-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
30 ug	DSP-3025	30 ug
60 ug	Placebo	60 ug

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kitasato University East Hospital; 🇯🇵 Asamizodai 2-1-1, Minami-ku, Sagamihara, Kanagawa, Japan