NCT07765966尚未招募1 期
A Phase 1, Open Label, Dose Escalation Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Early Efficacy of RXIM002, in Patients With Relapsed or Refractory Autoimmune Cytopenias
RiboX Therapeutics Ltd.0 个研究点目标入组 27 人开始时间: 2027年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 27
- 主要终点
- Incidence of treatment-emergent adverse events
研究概览
简要总结
The Phase 1 is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RXIM002 in patients with relapsed or refractory autoimmune cytopenias.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years of age
- •Diagnosed with primary ITP
- •Relapsed or refractory ITP
排除标准
- •Allergy or hypersensitivity to messenger ribonucleic acid (mRNA) vaccines or other RNA-LNP products
- •Any active infection
- •Heart failure, reduced kidney function, or liver abnormalities
研究组 & 干预措施
RXIM002
Experimental
Open-label, single arm with 3 dose-level cohorts of RXIM002
干预措施: RXIM002 (Biological)
结局指标
主要结局
Incidence of treatment-emergent adverse events
时间窗: Up to 104 weeks
Incidence of treatment-emergent adverse events
Dose-limiting toxicities (DLTs)
时间窗: Through Day 28 post-first dose
Dose-limiting toxicities (DLTs)
次要结局
未报告次要终点
研究者
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