NCT03494712已完成1 期
Safety, Tolerability and Pharmacokinetics of S 95010 After Single Escalating Intravenous Doses in Young Healthy Male Subjects. A Randomised, Doubleblind, Placebo-controlled, Monocentre, First-In-Human Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Safety assessed by incidence of Adverse Events
研究概览
简要总结
The purpose of the study is to assess, the safety and tolerability of single ascending doses of S 95010 and to assess the pharmacokinetics (PK) of S 95010.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Young healthy male subjects aged between 18 and 45 years (both inclusive)
排除标准
- •Any acute or chronic illness or clinically relevant findings such as livers,kidney, spleen, cardiovascular disease, eye disease in the selection/ inclusion visit examinations
- •Any abnormal laboratory result on blood and urine samples taken during screening, judged clinically relevant by the investigator
- •History of liver dysfunction or total bilirubin or ALT or AST or ALP or γGT > ULN at selection
- •History of renal dysfunction or GFR < 75mL/min/1.73 m2 (MDRD equation) at selection
研究组 & 干预措施
S 95010
Experimental
Increasing single doses of S 95010 to 5 subjects.
干预措施: S 95010 (Drug)
Placebo
Placebo Comparator
Increasing single doses of Placebo to 2 subjects.
干预措施: Placebo (Other)
结局指标
主要结局
Safety assessed by incidence of Adverse Events
时间窗: Through study completion, an average of 12 weeks
Safety criterion
次要结局
- The PK profile of S 95010 plasma concentration : Plasma half-life(During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12))
- The PK profile of S 95010 plasma concentration : Maximum plasma concentration (Cmax)(During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12))
- The PK (pharmacokinetic) profile of S 95010 plasma concentration : Area under the plasma concentration-time curve (AUC)(During Hospitalization Period (Day 1, Day 2, Day 3, Day 4) and during ambulatory follow-up period (at Week 2, Week 4 and Week 12))
研究者
研究点 (1)
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