A Phase II Clinical Study Evaluating the Efficacy and Safety of CM338 Injection in Subjects With Immunoglobulin A Nephropathy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The incidence of adverse events of CM338 in subjects with immunoglobulin A nephropathy
研究概览
简要总结
This study is a multicenter, randomized phase II clinical study to evaluate Efficacy and safety, while observing pharmacokinetic profiles, pharmacodynamic effects, and immunogenicity of CM338 in subjects with Immunoglobulin A(IgA) nephropathy.
详细描述
In 1968, immunoglobulin A nephropathy (IgAN) was developed by French pathologist Dr. Jean Berger and his colleague Dr. Nicole Hinglais that what is described as glomerular "immunoglobulin A (IgA)-immune globule" - immune globule Protein G (IgG) intercapillary deposition" of kidney disease, the main pathological feature of which is on the glomerulus IgA deposition, usually accompanied by local cell proliferation and stromal dilation. Since there is not enough specificity and spirit Biomarkers of sensitivity, the only way to confirm the diagnosis is renal biopsy.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-
- •Understand the nature of the study and sign the Informed Consent Form voluntarily.
- •Take effective contraception measures throughout the study period.
排除标准
- •Used other investigational drugs within 30 days before the first study administration.
- •With previous history of Human immunodeficiency virus(HIV) infection.
- •Treponema pallidum antibody positive in screening period.
- •May have active Mycobacterium tuberculosis infection.
- •Major surgery is planned during the study.
- •Other reasons the investigator believes that the subject is not suitable to participate in this study.
研究组 & 干预措施
Group B
CM338 will be injected subcutaneously.
干预措施: CM338 (Biological)
Group C
CM338 will be injected subcutaneously.
干预措施: CM338 (Biological)
Group A
CM338 will be injected subcutaneously.
干预措施: CM338 (Biological)
结局指标
主要结局
The incidence of adverse events of CM338 in subjects with immunoglobulin A nephropathy
时间窗: up to week 112
To evaluate the incidence of adverse events, including abnormalities of laboratory examination, physical examination, vital signs, 12-lead electrocardiogram (12-ECG) and others.
次要结局
未报告次要终点