临床试验/NCT01255501

NCT01255501已完成1 期

A First in Man Randomized Placebo Controlled Study of Single Ascending Intravenous Doses of NI-0701 in Healthy Volunteers

Light Chain Bioscience - Novimmune SA0 个研究点开始时间: 2010年12月7日最近更新: 2010年12月7日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
主要终点: Safety and tolerability of escalating single IV doses of NI-0701 in healthy volunteers

研究概览入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

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

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Non smokers
•Able to adhere to study visits and protocol requirements

排除标准

•Any clinical safety laboratory measurements value > Grade 1 on WHO Toxicity Scale
•Established or recurrent history of allergic reactions

研究组 & 干预措施

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

NI-0701

Experimental

干预措施: NI-0701 (Drug)

结局指标

主要结局

Safety and tolerability of escalating single IV doses of NI-0701 in healthy volunteers

次要结局

NI-0701 Pharmacokinetic parameters in healthy volunteers
NI-0701 plasma pharmacodynamic effects upon NI-0701 single intravenous infusion
Pharmacodynamic effects of NI-0701 on Histamine skin-induced wheal and flare
Immunogenicity of NI-0701

研究者

发起方

Light Chain Bioscience - Novimmune SA

申办方类型

Industry

相似试验

已完成

1 期

A Study to Evaluate How Well Single and Multiple Doses of GLPG4399 Are Tolerated in Healthy, Adult SubjectsHealthy

NCT04653467Galapagos NV88

已完成

1 期

A Safety and Tolerability Study of an Investigational Drug, ALN-TTRSC02, in Healthy SubjectsTransthyretin-mediated Amyloidosis (ATTR Amyloidosis)

NCT02797847Alnylam Pharmaceuticals80

已完成

1 期

Trial to Evaluate Safety and Tolerability of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C)Elevated LDL-Cholesterol (LDL-C)

NCT01437059Alnylam Pharmaceuticals32

已完成

1 期

Trial to Evaluate Safety, Tolerability, and Parmacokinetics of ALN-TTR02 in Healthy Volunteer SubjectsTTR-mediated Amyloidosis

NCT01559077Alnylam Pharmaceuticals17

已完成

1 期

A Phase 1, Single- and Multi-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered ALN-TTRSC (Revusiran) in Healthy VolunteersTTR-mediated Amyloidosis

NCT01814839Alnylam Pharmaceuticals85