NCT00621010已完成1 期
A Phase 1 Single Escalating Dose Study to Assess the Safety and Pharmacokinetics of CTS21166 Administered Intravenously to Healthy Adult Males
CoMentis1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability of single ascending doses of CTS21166 following intravenous administration
研究概览
简要总结
This study is the first human exposure for the drug candidate CTS21166 in healthy male volunteers
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male > age 21;
- •non-smoker (minimum 6 months);
排除标准
- •History or evidence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,neurologic, psychiatric, oncologic, or allergic (including anaphylactic drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease
- •History or evidence of intravenous illicit drug use, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C;
- •Participation in another clinical trial within 30 days prior to dosing
研究组 & 干预措施
Cohort
Experimental
干预措施: CTS21166 (ZPQ-21166) (Drug)
结局指标
主要结局
To evaluate the safety and tolerability of single ascending doses of CTS21166 following intravenous administration
次要结局
- To evaluate the pharmacokinetics(PK) of CTS21166 and its major metabolites as assessed in plasma
研究者
研究点 (1)
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