NCT05074550招募中1 期
Phase I, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of A Single Intravenous PPMX-T003 in Polycythemia Vera
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the Study
研究概览
简要总结
This is PhaseI Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of PPMX-T003 in Polycythemia Vera
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of PV according to either the 2008 or 2016 WHO classification criteria
- •PV patients being only treated with phlebotomy and the interval is 4-9 weeks
排除标准
- •Patients administrated drugs for PV treatment such as hydroxyurea or ruxolitinib (aspirin is excluded)
研究组 & 干预措施
PPMX-T003
Experimental
This drug should be administered within 48 hours after the phlebotomy. In addition, as a dose escalation design, 4 doses of 0.25 mg/kg, 0.4 mg/kg, 0.64 mg/kg, and 1 mg/kg are administered to the same subject, when the next phlebotomy required during observation period after the 1st administration.
干预措施: PPMX-T003 (Drug)
结局指标
主要结局
Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the Study
时间窗: 45 weeks
次要结局
- Evaluation of pharmacokinetics of PPMX-T003 after single dose(Day1,Day2,Day7)
- Examining the expression rate of anti-drug antibodies (ADA)(Day1,Day21,up to 45weeks)
研究者
研究点 (3)
Loading locations...
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