临床试验/NCT06520514

NCT06520514已完成1 期

Safety, Tolerability, and Relative Bioavailability of a Single Dose of Spesolimab Via Two Subcutaneous Modes of Delivery in Healthy Subjects (Mono-centric, Randomised, Parallel Group Design)

Boehringer Ingelheim1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2024年8月7日最近更新: 2025年6月29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: 60
试验地点: 1
主要终点: Occurrence of any treatment-emergent adverse event

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 main objectives of this trial is to investigate the safety and tolerability of a single dose of spesolimab administered in 2 different ways in healthy subjects.

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 50 Years（Adult）
性别: All
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

Reference group

Active Comparator

Reference treatment using the standard administration mode

干预措施: Spesolimab (Drug)

Test 1 group

Experimental

Treatment 1 using the test administration mode

干预措施: Spesolimab (Drug)

Test 2 group

Experimental

Treatment 2 using the test administration mode

干预措施: Spesolimab (Drug)

结局指标

主要结局

Occurrence of any treatment-emergent adverse event

时间窗: Up to day 120

次要结局

Cmax (maximum measured concentration of the analyte in plasma)(Up to day 120)
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)(Up to day 120)
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(Up to day 120)

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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