JPRN-jRCT2051220078已完成1 期
A Single-Administration Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Sotatercept (MK-7962) in Healthy Japanese Participants
Yoshiyuki Tanaka0 个研究点目标入组 26 人开始时间: 2022年8月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 55age old（—）
- 性别
- All
入选标准
- •1) Be in good health based on medical history, physical examination, vital signs measurements, and 12-Lead ECGs performed before randomization.
- •2) Be in good health based on laboratory safety tests obtained at the screening visit and before administration of the initial dose of study intervention.
- •3) Must have a body weight of at least 40 kg, BMI >=18.5 and <=30 kg/m2, inclusive.
排除标准
- •1) Have prior exposure to sotatercept or luspatercept.
- •2) History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
- •3) History of cancer (malignancy).
研究者
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