NCT04707131已完成1 期
A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate the Characteristics of the Safety, Tolerability and Pharmacokinetics of LEM-S401 in Healthy Adult Subjects
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
- Lemonex Inc.
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- The safety and tolerability of LEM-S401 evaluated by incidence of adverse events
研究概览
简要总结
The primary objective of the study is to assess the safety and tolerability of single dose of LEM-S401 in healthy adult subjects.
详细描述
This study is designed to evaluate the safety and tolerability of LEM-S401 administered as subcutaneous injection in healthy adult subjects.
Overall, 18 subjects will be studied in 3 groups. Each subject will receive LEM-S401 or placebo subcutaneously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects aged 19 to ≤ 65 years at screening
排除标准
- •Significant history or clinical manifestation of any hepatic, renal, neurological, psychiatric, respiratory, endocrine, hematological, tumor, genitourinary, cardiovascular, gastrointestinal, musculoskeletal, dermatological (eg, contact dermatitis, atopic dermatitis), or other
- •History of drug abuse or positive urine drug screen at screening
- •For all female subjects, pregnant (Urine-HCG positive) or breast-feeding subjects
研究组 & 干预措施
LEM-S401
Experimental
干预措施: LEM-S401 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
The safety and tolerability of LEM-S401 evaluated by incidence of adverse events
时间窗: Up to 16 days
Evaluation of safety and tolerability of subcutaneous injections of LEM-S401. Examination of any incidence of adverse events.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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