NL-OMON49624已完成2 期
A 4-part Phase 1/2 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 in healthy volunteers and in patients with immune thrombocytopenic purpura. - Safety and tolerability of M254 in HV and ITP patients.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •healthy male or female subjects
- •18 - 55 years of age
- •Weight: body weight must be within a range that allows for the planned M254
- •infusion time to be completed in * 4 hours.
- •BMI 18.5 - 30 kilograms/meter2
- •male or female diagnosed with ITP for at least 3 months
- •18 years and older
排除标准
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of
- •participation in another drug study within 90 days before the start of this
- •study or being a blood donor within 30 days from the start of the study. In
- •case of donating more than 1.5 liters of blood in the 10 months prior the start
- •of this study.
研究者
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