NCT07526194进行中（未招募）1 期
A Phase I Single-blind, Randomised, Placebo-controlled, Parallel Group Design Trial to Investigate the Safety, Tolerability and Pharmacokinetics of Single Rising Doses of BI 3821001 Administered to Healthy Trial Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
研究概览
简要总结
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 3821001 in healthy male trial participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
- •Age of 18 to 55 years (inclusive)
- •Body mass idnex (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- •Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply
排除标准
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 bpm
- •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
Dose group 2
Experimental
part A
干预措施: BI 3821001 (Drug)
Dose group 3
Experimental
part A
干预措施: BI 3821001 (Drug)
Dose group 1
Experimental
part A
干预措施: BI 3821001 (Drug)
Dose group 4
Experimental
part A
干预措施: BI 3821001 (Drug)
Placebo group
Placebo Comparator
干预措施: Placebo (Drug)
Dose group 5
Experimental
part A
干预措施: BI 3821001 (Drug)
Dose group 6
Experimental
part A
干预措施: BI 3821001 (Drug)
Dose group 7
Experimental
part B
干预措施: BI 3821001 (Drug)
Dose group 8
Experimental
part B
干预措施: BI 3821001 (Drug)
Dose group 9
Experimental
part B
干预措施: BI 3821001 (Drug)
结局指标
主要结局
Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator
时间窗: Up to 60 days
次要结局
- Area under the concentration-time curve of the analyte in blood over the time interval from 0 extrapolated to infinity (AUC0-∞)(Up to 60 days)
- Maximum measured concentration of the analyte in blood (Cmax)(Up to 60 days)
- Percentage of participants treated with investigational drug who experience a treatment-emergent adverse event(Up to 60 days)
研究者
研究点 (1)
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