NCT05985200已完成1 期
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Intravenous Doses of BI 3032950 in Healthy Male and Female Subjects (Single-blind, Randomised Within Dose Groups, Placebo-controlled Parallel-group Design)
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
- 40
- 试验地点
- 1
- 主要终点
- Occurrence of any treatment-emergent adverse event
研究概览
简要总结
The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics and pharmacodynamics following multiple rising intravenous doses of BI 3032950 in healthy male subjects and postmenopausal or surgically sterilised female subjects (women not of child bearing potential (WNOCBP)).
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
- •Healthy male subjects and female subjects not of child bearing potential (women not of child bearing potential (WNOCBP)) - postmenopausal or surgically sterilised female subjects 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 65 years (inclusive)
- •Body mass index (BMI) of 18.5 to 29.9 kg/m^2 (inclusive)
- •Signed and dated written informed consent in accordance with International conference on harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
- •Male subjects (including male subjects with pregnant partners) who meet any of the criteria listed in the protocol for a highly effective contraception from the first administration of trial medication until the end of study (EoS) visit.
- •Postmenopausal or surgically sterilised female subjects (WNOCBP) who are:
- •Confirmed surgically sterilised (including hysterectomy, bilateral salpingectomy and bilateral oophorectomy), or
- •Postmenopausal, defined as at least 1 year of spontaneous amenorrhea without an alternative medical cause 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 millimetre mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 100 beats per minute (bpm); in case of documented 'white coat hypertension' the decision for eligibility is left to the investigator
- •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
BI 3032950: Dose group 1
Experimental
干预措施: BI 3032950 (Drug)
BI 3032950: Dose group 2
Experimental
干预措施: BI 3032950 (Drug)
BI 3032950: Dose group 3
Experimental
干预措施: BI 3032950 (Drug)
BI 3032950: Dose group 4
Experimental
干预措施: BI 3032950 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo matching BI 3032950 (Drug)
结局指标
主要结局
Occurrence of any treatment-emergent adverse event
时间窗: Up to Day 137
次要结局
- Area under the concentration-time curve of the analyte in serum over a uniform dosing interval τ (AUCτ,)(From Day 22 to Day 134)
- Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator(Up to Day 137)
- Maximum measured concentration of the analyte in serum (Cmax)(From Day 22 to Day 134)
研究者
研究点 (1)
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