NCT01459562已完成1 期
A Randomized Double-blinded Placebo Controlled Single Center Phase I Study of Escalating Single Intravenous Doses of NI-0501 in Healthy Volunteers
Swedish Orphan Biovitrum2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Safety and tolerability of escalating single IV doses of NI-0501.
研究概览
简要总结
The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy adults between 18 and 50 years old
- •non smokers
- •able to adhere to study protocol requirements
排除标准
- •any abnormal clinical safety laboratory parameters
研究组 & 干预措施
NI-0501
Experimental
干预措施: NI-0501 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of escalating single IV doses of NI-0501.
时间窗: AEs at: Study Day (SD) 1 pre-infusion, SD1 at 1, 2, 4, 8, 10, 12 hrs post infusion start, SD 2, SD 3, SD 5, SD 8, Wk 2, Wk 4, Wk 6, Wk 8
次要结局
- Pharmacokinetics parameters, Determination of any pharmacodynamic effects, Immunogenicity of NI-0501(PK/PD at: Study Day (SD) 1 pre-infusion, SD1 at 1, 2, 4, 8, 10 hrs post infusion start, SD 2, SD 3, SD 5, SD 8, Wk 2, Wk 4, Wk 6, Wk 8, Immunogenicity: SD1 pre-infusion, Wk 8)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
A Safety PK/PD Study of SLV337 in Patients With Type 2 DiabetesType 2 DiabetesNCT00924534Abbott Products61
已完成
1 期
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-54861911 in Healthy Volunteers Compared With PlaceboHealthyNCT01827982Janssen Research & Development, LLC56
终止
4 期
A Study to Evaluate the Use of Extended Release Alprazolam in the Treatment of Adolescents With Panic DisorderPanic DisorderNCT00635531Pfizer's Upjohn has merged with Mylan to form Viatris Inc.16
撤回
2 期
Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery PatientsCardiopulmonary BypassHypotensionNCT00482287Meditor Pharmaceuticals Ltd.
招募中
1 期
A Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RS-C1001 Tablets in Chinese Healthy SubjectsDyslipidemiaNCT0666942972