An Open-label Phase I Trial to Assess Pharmacokinetics and Safety of Single Subcutaneous Doses and Single Intravenous Doses of BI 655130 in Healthy Chinese Male and Female Subjects (Single Doses, Open-label Study in Parallel-group Design).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-time Curve of Spesolimap in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
研究概览
简要总结
The primary objective of this trial is to investigate pharmacokinetics, including dose proportionality, following single intravenous and subcutaneous doses of spesolimab in healthy Chinese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects (at least three subjects for each gender within each dose group) 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), respiratory rate (RR), body temperature), 12-lead ECG, and clinical laboratory tests.
- •Chinese ethnicity, according to the following criteria: Ethnic Chinese, born in China and have 4 ethnic grandparents who were all born in China
- •Age of 18 to 45 years (inclusive)
- •Body weight ≥50 kg for male and ≥45 kg for female with body mass index (BMI) range ≥19 and < 26 kg/m2 at visit 1
- •Signed and dated written informed consent prior to admission to the trial, in accordance with GCP and local legislation
- •Female subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 16 weeks after trial completion [c03320877-06]:
- •Women of childbearing potential (WOCBP)1 must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the subject information
- •A vasectomised sexual partner (vasectomy at least one year prior to enrolment)
- •Surgically sterilised (including hysterectomy)
- •Postmenopausal, defined as at least one year of spontaneous amenorrhoea (in questionable cases a blood sample with simultaneous levels of follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 mg/L is confirmatory)
排除标准
- •Major surgery (major according to the investigator's assessment) performed within 12 weeks prior to treatment or planned within 12 months after screening, e.g. hip replacement
- •Any finding in the medical examination (including BP, PR, RR, Body temperature or 12-lead 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 50 to 90 mmHg, or PR 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
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- •History of relevant orthostatic hypotension, fainting spells, or blackouts
- •Chronic or relevant acute infections including active and latent tuberculosis, human immunodeficiency virus (HIV) or viral hepatitis; QuantiFERON tuberculosis (TB) test will be performed at screening Further exclusion criteria apply
研究组 & 干预措施
Spesolimap (BI 655130) - 450 milligram (mg) - intravenous (IV)
A single dose of 450 mg Spesolimap was administered as solution for infusion intravenously over 90 minutes (mins) after an overnight fast.
干预措施: Spesolimap (Drug)
Spesolimap - 900 mg - IV
A single dose of 900 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.
干预措施: Spesolimap (Drug)
Spesolimap - 1200 mg - IV
A single dose of 1200 mg Spesolimap was administered as solution for infusion intravenously over 90 mins after an overnight fast.
干预措施: Spesolimap (Drug)
Spesolimap - 300 mg - subcutaneous (SC)
A single dose of 300 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 seconds (s) after an overnight fast.
干预措施: Spesolimap (Drug)
Spesolimap - 600 mg - SC
A single dose of 600 mg Spesolimap was administered as solution for injection subcutaneously in the abdominal region within 60 s after an overnight fast.
干预措施: Spesolimap (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve of Spesolimap in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
时间窗: Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.
Area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. The time frames differed slightly between intravenous (IV) and subcutaneous (SC) administration. The prefix 'IV' indicates when IV was measured only. The prefix 'SC' indicates when SC was measured only. No prefix means that measurement time points were identical for IV and SC administration.
Maximum Measured Concentration of the Spesolimap in Plasma (Cmax)
时间窗: Within 3 hours (h) before drug administration and SC: 30 minutes (min), IV: 1h 30 min, 2h, 3h, 4h, 8h, 12h, 24h, 48h, 72h, 96h, 120h, 144h, 168h, 336h, 504h, 672h, 840h, 1008h, 1344h, 1680h, 2184h, 2856h, 3528h, 4200h after drug administration.
Maximum measured concentration of the Spesolimap in plasma (Cmax) The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. Area under the concentration-time curve of Spesolimap in plasma over the time interval from 0 extrapolated to infinity (AUC0-8). The geometric mean and geometric coefficient of variation were calculated by noncompartmental analysis. The time frames differed slightly between intravenous (IV) and subcutaneous (SC) administration. The prefix 'IV' indicates when IV was measured only. The prefix 'SC' indicates when SC was measured only. No prefix means that measurement time points were identical for IV and SC administration.
次要结局
- Number of Participants With Treatment-emergent Adverse Events (AE)s(Frome day of drug administration until 16 weeks thereafter, up to 16 weeks.)
- Number of Participants With Drug-related Adverse Events (AEs).(Frome day of drug administration until 16 weeks thereafter, up to 16 weeks.)