临床试验/NCT02852824

NCT02852824已完成1 期

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Intravenous Doses of BI 655130 (Double-blind, Partially Randomised Within Dose Groups, Placebo-controlled Parallel Group Design) and One Single Intravenous Dose of BI 655130 (Single-blind, Partially Randomised, Placebo-controlled) in Healthy Male Subjects

Boehringer Ingelheim1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2016年8月10日最近更新: 2024年3月18日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Boehringer Ingelheim
入组人数: 40
试验地点: 1
主要终点: Percentage of Subjects With Drug-related Adverse Events (AEs).

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

The primary objective of this trial is to investigate the safety and tolerability of BI 655130 in healthy male subjects following IV administration of multiple rising doses. The study will also explore safety and tolerability following a single IV administration.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

BI 655130 (spesolimab)

Experimental

干预措施: BI 655130 (spesolimab) (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

Percentage of Subjects With Drug-related Adverse Events (AEs).

时间窗: From first drug administration until the end-of-trial examination; up to 179 days. (For both, Multiple rising dose part and single dose part)

Percentage of subjects with investigator defined drug-related adverse events (AEs).

次要结局

Area Under the Concentration-time Curve of the BI 655130 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)(Pharmacokinetic samples were collected at 2 hours pre-dose and 1, 2, 3, 4, 8, 12, 24, 48, 72, 96, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2184, 2856, 3528 and 4200 hours after drug administration.)
Maximum Measured Concentration of the BI 655130 in Plasma (Cmax)(Up to 4200 hours. Individual time points are provided in detail in description.)
Area Under the Concentration-time Curve of the BI 655130 in Plasma Over a Uniform Dosing Interval τ After Administration of the First Dose (AUCτ,1)(Up to 4200 hours. Individual time points are provided in detail in description.)
Maximum Measured Concentration of BI 655130 in Plasma After the Fourth Dose (Cmax,4)(Up to 4200 hours. Individual time points are provided in detail in description.)
Area Under the Concentration Time Curve of BI 655130 in Plasma After the Fourth Dose (AUCτ,4)(Up to 4200 hours. Individual time points are provided in detail in description.)

研究者

发起方

Boehringer Ingelheim

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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