NL-OMON48273已完成不适用
Phase I, Single-Center, Randomized, Placebo-Controlled, Double-Blinded Study with Single Ascending Doses, Evaluating the Safety and Tolerability of T20K, Administered by a 1-hr IV Infusion in Healthy Male Volunteers - CS0312 Cyxone
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cyxone AB
- 入组人数
- 40
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
- •1. Male subject between 18 and 55 years, inclusive, at the time of screening.
- •2. Healthy as determined by the Investigator, based upon a medical evaluation
- •including medical history, physical examination and clinical laboratory testing
- •performed at Screening.
- •3. A body weight of *60 kg and a body mass index (BMI) *18.0 kg/m2 and * 30.0
- •kg/m2 at Screening.
排除标准
- •1. Evidence of active and/or chronic disease that, in the Investigator*s
- •opinion, could interfere with the study procedures or could adversely affect
- •the safety of the subject or could affect the safety and/or pharmacokinetic
- •(PK) evaluations.
- •2. History of drug abuse.
- •3. Positive urine drug screen and/or positive alcohol breath test at Screening
- •or on Day -1.
研究者
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