NCT04076293已完成1 期
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912(Sonefpeglutide) in Healthy Korean Subjects
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年10月8日最近更新:
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
- 40
- 试验地点
- 1
- 主要终点
- Number of Participants With Significant Findings Observed for Hematology
研究概览
简要总结
A First-in-Human, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent prior to performing any of the Screening visit procedures.
- •Korean males and females ≥ 19 and ≤ 60 years of age at the Screening visit
排除标准
- •Subject with a history or presence of clinically significant active diseases.
- •Subject who has participated in other clinical studies (including bioequivalence tests) within 6 months before the Screening visit and has received IPs
研究组 & 干预措施
HM15912
Experimental
干预措施: HM15912 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Significant Findings Observed for Hematology
时间窗: after single subcutaneous (SC) doses for 44 days
Number of Participants With Treatment-emergent Adverse Events of HM15912
时间窗: after single subcutaneous (SC) doses for 44 days
Number of participants with any treatment-emergent adverse events related to study medication.
次要结局
- Concentration Max Profile of HM15912(after single subcutaneous (SC) doses at day 1,2,3,4,5,6,7,10,17 and 30)
研究者
研究点 (1)
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