NCT05366634已完成1 期
A Phase 1, Randomized, Placebo-controlled, Single-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MDK-703 in Healthy Adult Volunteers
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Assessment of adverse events after single injection of MDK-703
研究概览
简要总结
MDK-703-101 is a single ascending dose study, to determine the safety, tolerability, and PK/PD of MDK-703 in healthy adult subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or ECGs.
排除标准
- •1. Significant history or clinical manifestation of any metabolic, autoimmune, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder.
研究组 & 干预措施
Cohort 1
Experimental
Single injection of MDK-703 (dose level 1) or matching placebo
干预措施: MDK-703 or Placebo (Biological)
Cohort 2
Experimental
Single injection of MDK-703 (dose level 2) or matching placebo
干预措施: MDK-703 or Placebo (Biological)
Cohort 3
Experimental
Single injection of MDK-703 (dose level 3) or matching placebo
干预措施: MDK-703 or Placebo (Biological)
结局指标
主要结局
Assessment of adverse events after single injection of MDK-703
时间窗: 8 weeks
Adverse events after single Injection
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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