ACTRN12614000200684已完成1 期
A Phase I, Randomised, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous Doses of ATL1102 Alone and in Combination with G-CSF in Healthy Volunteers
Antisense Therapeutics0 个研究点目标入组 10 人开始时间: 2014年2月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
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
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- Male
入选标准
- •Provide written informed consent
- •- Male subjects 18 – 50 years of age inclusive
- •- Body Mass Index (BMI) >=19 and <= 32 kg/m2
- •- Healthy as determined by medical and drug history, physical examination, vital signs, clinical laboratory testings including urinalysis, and ECG.
排除标准
- •- Allergy and/or hypersensitivity to any of the ingredients of ATL1102 or to E. coli derived proteins, filgrastim, or any component of Neupogen (registered trademark).
- •- History or presence of clinically significant haematological abnormalities
- •- Current or prior history within the last 5 years of cancer (except for treated BCC SCC of the skin with no evidence of recurrence)
- •- History or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, ocular, or infectious disease, or any acute infectious disease.
- •- Received an investigational drug within 30 days or 5 half-lives prior to the first dose of study drug, whichever is the longer period.
- •- Blood donation or loss of >500ml within 3 months prior to the first dose of study drug
研究者
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