NCT00925678已完成1 期
A Double-blind, Placebo-controlled, Randomised Study to Investigate the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of DSP-3025 Administered Intranasally to Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of Season
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 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
简要总结
Investigate safety/tolerability after a single dose intranasal administration of DSP-3025 comparator placebo to healthy male volunteers and seasonal allergic rhinitis male patients out of season.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
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
- •History of cedar and/or Japanese cypress pollen induced seasonal allergic rhinitis for at least the previous 2 years (only Allergic rhinitis)
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 asthma
研究组 & 干预措施
1
Experimental
干预措施: DSP-3025 (Drug)
2
Placebo Comparator
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
次要结局
- Pharmacokinetics
- Clinical chemistry, haematology, urinalysis
- Nasal symptoms and peak nasal inspiratory flow
- Biomarkers nasal lavage and blood
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
DSP-3025 A Phase 1 Study of Healthy Male VolunteersHealthyNCT01124396Sumitomo Pharma Co., Ltd.24
已完成
3 期
Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)Seasonal Allergic Rhinitis (SAR)NCT03463031Glenmark Specialty S.A.446
已完成
1 期
Tolerability/Safety of Intranasal AZD8848 in Healthy Male Volunteers and Seasonal Allergic Rhinitis Male Patients Out of SeasonHealthyAllergic RhinitisNCT00688779AstraZeneca130
已完成
1 期
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly Japanese, and Healthy Younger Adult Japanese SubjectsHealthyNCT02857777Janssen Research & Development, LLC37
已完成
1 期
Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Elderly and and Healthy Younger Adult ParticipantsHealthyNCT02345148Janssen Research & Development, LLC16