KCT0007816尚未招募未知
A Phase 1, Randomized, Open-label, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled syringe of CT-P47 in Healthy Subjects
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- Celltrion
- 入组人数
- 268
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 55(Year)（—）
- 性别
- All
入选标准
- •1. Healthy male or female subjects between the ages of 19 to 55 years,both inclusive.
- •2. Subject with a body weight of =60 and =100 kg for male and =50 and =100 kg for female and a BMI between 18.5 and 28.0 kg/m2 (both inclusive) when rounded to the nearest tenth.
排除标准
- •Exclusion Criteria:
- •1. A medical history and/or condition that is considered significant
- •2. Clinically significant allergic reactions, hypersensitivity
- •3. History or current infection of hepatitis B virus, hepatitis C virus, human immunodeficiency virus, or syphilis
- •4. Active or latent Tuberculosis
- •5. History of malignancy
- •6. Previous exposure to tocilizumab or any drug that targets IL-6
研究者
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