jRCT2031250859招募中不适用
Single ascending dose study to assess the safety, pharmacokinetics and pharmacodynamics of DS2001a in healthy participants
未提供0 个研究点目标入组 64 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 45age old under(—)
- 性别
- All
入选标准
- •Healthy participants (males or females)
- •Age: 18 to 45 years at the time the ICF is signed.
- •A body mass index (BMI) >= 18.5 and < 25.0 kg/m^2 at screening test.
排除标准
- •Having a history of serious disease attributed to central nervous, cardiovascular, respiratory, blood and hematopoietic, gastrointestinal, hepatic and renal, thyroid, pituitary gland, or adrenal disorder, and participation in the study potentially endangering the participant, as judged by the investigator or sub-investigator.
- •Having clinically significant participant-reported symptoms/findings (e.g. headache, dizziness), objective symptoms/findings (e.g. decreased blood pressure), abnormalities on an ECG, or laboratory values outside the study site's reference range at screening, as observed by the investigator or sub-investigator. (However, the participant will not be excluded if these symptoms/findings would not affect participation in the study, as judged by the investigator or sub-investigator.)
- •Having a history of hypersensitivity to drugs or other substances or being idiosyncratic (e.g. Having penicillin allergy)
- •Having alcohol or drug dependencies
- •Having superficial skin infection within 7 days before the screening test.
- •Having a history of recurrent oral herpes or recurrent genital herpes.
- •Having history of histoplasmosis, listeriosis, coccidioidomycosis, thrush, pneumocystis pneumonia, aspergillosis, or other invasive opportunistic infections, parasitic infections, or pulmonary tuberculosis
- •Having a history of immunodeficiency disorders or being immunocompromised due to such conditions.
研究者
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