ISRCTN92655801已完成1 期
A Phase IA, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of RO7497987 in single and multiple ascending doses in healthy volunteers
Roche (United States)0 个研究点目标入组 60 人开始时间: 2021年11月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- 性别
- All
入选标准
- •1. Age =18 years and =65 years at the time of signing Informed Consent Form (ICF)
- •2. A minimum weight of 40 kg at screening
- •3. Body mass index of 18-32 kg/m² at screening
- •4. Adequate hematologic and end-organ function
排除标准
- •1. History or active diseases of bone marrow disorders
- •2. History of malignancy within 5 years prior to screening
- •3. Vaccine immunization within 2 weeks prior to initiation of study drug
- •4. Known infection/COVID-19 positive or persistent symptoms of SARS-CoV-2
- •5. HIV positive
- •6. Active Hepatitis B or Hepatitis C infections
- •7. Current tobacco use
- •8. History or currently active of autoimmune disease
- •9. Significant cardiovascular disease
- •10. Known clinically significant liver and renal diseases
研究者
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