临床试验/NCT01124396

NCT01124396已完成不适用

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

Sumitomo Pharma Co., Ltd.1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2010年4月最近更新: 2022年4月12日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Sumitomo Pharma Co., Ltd.
入组人数: 24
试验地点: 1
主要终点: Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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

研究设计

研究类型: Observational
观察模型: Cohort
时间视角: Prospective

入排标准

年龄范围: 20 Years 至 39 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Body mass index (BMI) between 18.5 and 25 kg/ m2 and a weight between 50 and 80 kg
•No clinically relevant abnormal findings

排除标准

•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

研究组 & 干预措施

30 ug

干预措施: DSP-3025 (Drug)

60 ug

干预措施: Placebo (Drug)

结局指标

主要结局

Incidence/nature of adverse events, 12-lead ECG, pulse, BP, body temperature, spirometry

时间窗: During the study

次要结局

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)

研究者

发起方

Sumitomo Pharma Co., Ltd.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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