NCT07486115招募中1 期
A Phase 1, Randomised, Single-blind, Placebo-controlled Trial to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BI 3814916 in Healthy Male and Female Subjects
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Occurrence of any treatment-emergent adverse events (AEs) 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 3814916 in healthy male and female trial participants.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 18 to 65 years (inclusive) at the time of screening
- •Body mass index (BMI) of 18.5 to 30.0 kg/m² (inclusive) at screening
- •Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- •Agree to refrain from strenuous or unusual exercise/activity (for example heavy lifting, weight training, intense aerobics classes, etc.) for at least 72 hours prior to study visits.
- •Agree to abstain from alcoholic beverages and/or soft drugs (e.g., marijuana) for at least 48 hours prior to study visits.
- •Further inclusion criteria apply.
排除标准
- •Any finding in the medical examination (including blood pressure (BP), pulse rate (PR), temperature or electrocardiogram (ECG)) deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic BP outside the range of 90 to 140 mmHg, diastolic BP outside the range of 45 to 90 mmHg, or PR outside the range of 45 to 100 beats per minute (bpm)
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance Further exclusion criteria apply.
研究组 & 干预措施
Part B: multiple rising dose arm
Experimental
干预措施: BI 3814916 (Biological)
Part B: placebo arm
Placebo Comparator
干预措施: Placebo matching BI 3814916 (Drug)
Part A: single rising dose arm
Experimental
干预措施: BI 3814916 (Biological)
Part A: placebo arm
Placebo Comparator
干预措施: Placebo matching BI 3814916 (Drug)
结局指标
主要结局
Occurrence of any treatment-emergent adverse events (AEs) assessed as drug-related by the investigator
时间窗: up to 111 days
次要结局
- Part B: Maximum measured concentration of the analyte in serum at steady state (Cmax,ss), if steady state can be reasonably assumed(up to 108 days)
- 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 72 days)
- Part A: Maximum measured concentration of the analyte in serum (Cmax)(up to 72 days)
- Part B: Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state (AUCτ,ss), if steady state can be reasonably assumed(up to 108 days)
研究者
研究点 (1)
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