An Open Label, Sequential, Dose Escalation, Repeat-dose Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRTX-100 in Adult Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 7
- 主要终点
- Evaluate the overall safety of PRTX-100 during the 3 month study duration
研究概览
简要总结
The primary purpose of this study is to evaluate the safety of multiple doses of Staphylococcal protein A (PRTX-100) in adult patients with Idiopathic Thrombocytopenia Purpura (ITP). The pharmacokinetics, immunogenicity and pharmacodynamics will also be studied.
Patients will be enrolled into 1 of 3 dose groups and receive 4 weekly IV doses of PRTX-100. A Safety Monitoring Committee will review safety data through Day 28 for the first 5 patients in a dose group before escalation to the next higher dose level. Patients will be followed for 8 weeks after dosing for safety, PK, immunogenicity and effect on platelet count(pharmacodynamics).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic ITP > 4 months
- •Mean platelet count <50 x 10^9/L for patients not receiving corticosteroids; or mean platelet count >=50 x 10^9/L for patients receiving stable dose of corticosteroids
排除标准
- •Splenectomy within 45 days of screening
- •Rituximab within 6 months prior to screening
- •Cyclophosphamide, vincristine, or any other non-monoclonal antibody treatment for ITP within 3 months prior to screening
- •IVIG, WinRho or other anti-RhD within 30 days prior to screening
研究组 & 干预措施
PRTX-100 (Staphylococcal protein A)
Cohort 1: 0.075 mcg/kg
Cohort 2: 0.15 mcg/kg
Cohort 3: 0.30 mcg/kg
干预措施: PRTX-100 (Staphylococcal protein A) (Drug)
结局指标
主要结局
Evaluate the overall safety of PRTX-100 during the 3 month study duration
时间窗: 3 months
次要结局
- Explore immunogenicity of multiple doses of PRTX-10(3 months)
- Evaluate treatment effect on platelet count(3 months)
- Characterize the pharmacokinetics of multiple doses of PRTX-100(over the first 35 days)