临床试验/NCT03175211

NCT03175211已完成1 期

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Subcutaneous Doses of BI 456906 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)

Boehringer Ingelheim1 个研究点分布在 1 个国家目标入组 20 人开始时间: 2017年6月30日最近更新: 2018年7月16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: 20
试验地点: 1
主要终点: [N (%)] of subjects with drug-related adverse events.

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 456906 in healthy subjects following single rising doses.

The secondary objective is the exploration of the pharmacokinetics including dose proportionality, and pharmacodynamics (PD) of BI 456906 after single dosing

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: Single (Participant)

入排标准

年龄范围: 18 Years 至 45 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 456906

Experimental

干预措施: BI 456906 (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

[N (%)] of subjects with drug-related adverse events.

时间窗: Up to 672 hours

次要结局

Cmax (maximum measured concentration of the analyte in plasma)(up to 672 hours)
AUC0-168 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 168h)(up to 168 hours)

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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