Pharmacokinetics, Pharmacodynamics and Safety of Ziltivekimab Versus Placebo in Chinese Participants With Chronic Kidney Disease and Systemic Inflammation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 7
- 主要终点
- Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, multiple doses [MD] (AUCτ,MD)
研究概览
简要总结
This study is conducted to see how the ziltivekimab works in the body of Chinese people with chronic kidney disease and systemic inflammation. Participants will either get ziltivekimab (active medicine) or placebo (a dummy medicine which has no effect on the body. Participants' chance of getting ziltivekimab or placebo is the same.
Participants will get their study medicine in a pre-filled syringe. The study doctor or staff will do 3 injections of study medicine during clinical visits.
The study is expected to last for about 6 months. Participants will have blood and urine samples taken at all of the clinic visits. Participants will have their heart examined using electrodes (electrocardiogram).
Women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Participants will receive placebo at weeks 0, 4 and 8.
干预措施: Placebo (Drug)
Ziltivekimab 15 mg
Participants will receive ziltivekimab at weeks 0, 4 and 8.
干预措施: Ziltivekimab (Drug)
结局指标
主要结局
Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, multiple doses [MD] (AUCτ,MD)
时间窗: During 3rd dosing interval (week 8 to week 12)
Nanograms per millilitre\*days (ng/mL\*days)
次要结局
- Maximum plasma concentration of ziltivekimab after 3rd dose (Cmax,MD)(After last dose (week 8) to end of study (week 20))
- Change in hs-CRP (high-sensitivity C-reactive protein(From baseline (week 0) to end of treatment (week 12))
- Area under the ziltivekimab plasma concentration-time curve in a 4-week dosing interval, single dose [SD](During 1st dosing interval (day 0 to week 4))
- Elimination half-life (t½)(After last dose (week 8) to end of study (week 20))