NCT06594146进行中（未招募）2 期
A Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Initial Efficacy of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia
Keymed Biosciences Co.Ltd1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2024年11月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Adverse event
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial efficacy of CM313 (SC) injection in patients with primary immune thrombocytopenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old ≤ 75 years old, male or female.
- •Fully understand and are able to comply with the requirements of the protocol and voluntarily sign the informed consent form.
排除标准
- •Previously received allogeneic stem cell transplantation or organ transplantation.
- •Laboratory abnormalities with clinical significance at screening visit.
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeeding during the study period; Male partners who plan to become pregnant during the study period.
- •With any other situations that are not suitable for participation in this study by the investigator.
研究组 & 干预措施
Group 1
Experimental
CM313 injection and placebo
干预措施: CM313 injection (Biological)
Group 1
Experimental
CM313 injection and placebo
干预措施: placebo (Other)
Group 2
Experimental
CM313 injection and placebo
干预措施: CM313 injection (Biological)
Group 2
Experimental
CM313 injection and placebo
干预措施: placebo (Other)
Group 3
Experimental
CM313 injection and placebo
干预措施: CM313 injection (Biological)
Group 3
Experimental
CM313 injection and placebo
干预措施: placebo (Other)
结局指标
主要结局
Adverse event
时间窗: Up to Week 16
Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
次要结局
未报告次要终点
研究者
研究点 (1)
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