NCT06081530已完成1 期
Single-blind, Randomised, Placebo-Controlled Trial on the Safety, Tolerability, and Pharmacokinetics of Single Rising Doses and Multiple Doses of Intravenous BI 3802876 in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Part A and Part B: Occurrences of any drug-related AEs between first drug administration (BI 3802876 or placebo) and end of the residual effect period (REP)
研究概览
简要总结
The main objective of this trial is to investigate the safety, tolerability, and pharmacokinetics of BI 3802876 when administered in different doses in healthy male volunteers. The primary objective is to descriptively assess the frequency of drug-related adverse events (AEs) in subjects treated with BI 3802876, as compared to placebo. The secondary objective is to descriptively assess pharmacokinetic parameters.
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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (temperature, blood pressure, pulse), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of ≥18 to ≤55 years at screening
- •Body mass index (BMI) of ≥ 19.0 to ≤ 28.0 kg/m2 at screening. A minimum body weight of 65 kg at screening
- •Signed and dated written informed consent prior to admission to the study, in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation
排除标准
- •Any finding in the medical examination (including blood pressure (BP), pulse rate, or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •Three repeated measurements of systolic BP outside the range of 80 to 130 mm Hg, diastolic BP outside the range of 50 to 80 millimetre of mercury (mmHg), or pulse outside the range of 45 to 90 beats per minute.
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- •Further exclusion criteria apply
研究组 & 干预措施
Part A: BI 3802876 dose group 1
Experimental
干预措施: BI 3802876 (Drug)
Part A: BI 3802876 dose group 2
Experimental
干预措施: BI 3802876 (Drug)
Part A: BI 3802876 dose group 3
Experimental
干预措施: BI 3802876 (Drug)
Part A: BI 3802876 dose group 4
Experimental
干预措施: BI 3802876 (Drug)
Part A: BI 3802876 dose group 5
Experimental
干预措施: BI 3802876 (Drug)
Part A: BI 3802876 dose group 6
Experimental
干预措施: BI 3802876 (Drug)
Part A: Placebo
Placebo Comparator
干预措施: Placebo matching BI 3802876 (Drug)
Part B: BI 3802876
Experimental
干预措施: BI 3802876 (Drug)
Part B: Placebo
Placebo Comparator
干预措施: Placebo matching BI 3802876 (Drug)
结局指标
主要结局
Part A and Part B: Occurrences of any drug-related AEs between first drug administration (BI 3802876 or placebo) and end of the residual effect period (REP)
时间窗: up to Day 35 for Part A and up to Day 117 for Part B
次要结局
- Part A: Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)(up to Day 35)
- Part B: Maximum measured concentration of the analyte in serum at steady state, if steady state can be reasonably assumed (Cmax,ss)(up to Day 117)
- Part A: Maximum measured concentration of the analyte in serum (Cmax)(up to Day 35)
- Part B: Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state, if steady state can be reasonably assumed (AUCτ,ss)(up to Day 117)
研究者
研究点 (1)
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