NCT05314231已完成1 期
A Phase 1b, Open-Label, Single-Dose Pharmacokinetic Study of Subcutaneous ALXN1720 in Adult Participants With Varying Degrees of Proteinuria
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
- 13
- 试验地点
- 2
- 主要终点
- Serum Concentration of ALXN1720
研究概览
简要总结
The primary objective of this study is to assess the impact of proteinuria on the pharmacokinetic (PK) of a single dose of ALXN1720 in participants with proteinuria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented diagnosis of Lupus Nephritis, IgA Nephropathy, Primary Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Diabetic Nephropathy, Hypertensive Nephrosclerosis, Minimal Change Disease, Thin Basement Membrane Nephropathy or Membranoproliferative Glomerulonephritis (all forms). Other cause of kidney disease may be included per investigator agreement with the Sponsor
- •Proteinuria >=1 based on absolute amount in grams per day (g/d) as measured in one complete and valid 24-hour urine collection during Screening
- •Body weight ≥ 40 kg at Screening
排除标准
- •Kidney transplant
- •Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 during Screening
- •Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.
- •Treatment with complement inhibitors at any time.
- •Treatment with rituximab within 6 months before initiation of study drug on Day 1; or, planned treatment with rituximab within 3 months after initiation of study drug on Day
- •Participation in another investigational drug or investigational device study within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.
研究组 & 干预措施
ALXN1720
Experimental
Participants will receive a single dose of ALXN1720, given as a SC infusion at a dose of 1500 mg.
干预措施: ALXN1720 (Drug)
结局指标
主要结局
Serum Concentration of ALXN1720
时间窗: Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57
次要结局
- Number of Participants With Treatment-Emergent Adverse Events(Day 1 (Predose) through Follow-up (Day 92))
- Serum Concentration of Free and Total Complement Component 5 (C5)(Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57)
- Number of Participants With Antidrug Antibodies (ADAs) to ALXN1720(Day 1 (predose) through Day 57)
研究者
研究点 (2)
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