ACTRN12616000846426已完成1 期
A single dose ascending and repeated dose, randomised, double-blind, placebo-controlled study to assess the safety, pharmacokinetics and pharmacodynamics of CSL324 in healthy, adult male and female subjects.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CSL Limited
- 入组人数
- 56
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Healthy, male or female, 18 to 55 years of age
- •- Body mass index range of 18.5 to 32.0 kg/m^2, inclusive, and weight at least 50 kg and less than 100 kg
- •- Females must be of non-childbearing potential
- •- Male subject and their female spouse/partners who are of childbearing potential must be using 2 forms of highly effective birth control
排除标准
- •- History or evidence of any clinically significant cardiovascular, gastrointestinal, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy
- •- History of venous thrombosis, polycythaemia or thrombophilia
- •- History of autoimmune disease with the exception of seasonal allergic rhinitis managed without systemic glucocorticoid treatment
- •- Any history of cyclic neutropenia or a Screening absolute neutrophil count < 2.0 × 10^9/
研究者
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