NCT07348055招募中1 期
A Phase Ib/IIa Clinical Trial Evaluating the Safety, Tolerability, and Efficacy of GR1803 Injection in Subjects With Systemic Lupus Erythematosus
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- incidence of adverse event
研究概览
简要总结
to evaluate the safety and efficacy of GR1803 in the treatment of patients with systemic lupus erythematosus
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •comfirmed diagnosis of systemic lupus erythematosus
- •SLEDAI-2K≥6 分
- •written informed consent and ability to comply with protocol requirements
- •have received adequate dose of glucocorticoids, antimalarials, immunosuppressants for 3 months
排除标准
- •with unstable acute and chronic diseases
- •active infection
- •history of malignant tumor within 5 years
研究组 & 干预措施
GR1803 injection dose 2
Experimental
干预措施: GR1803 injection (Biological)
GR1803 injection dose 3
Experimental
干预措施: GR1803 injection (Biological)
GR1803 injection dose 4
Experimental
干预措施: GR1803 injection (Biological)
GR1803 injection dose 1
Experimental
干预措施: GR1803 injection (Biological)
结局指标
主要结局
incidence of adverse event
时间窗: 52 week
incidence of adverse event
次要结局
- efficacy of GR1803(52 week)
研究者
研究点 (1)
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