NL-OMON42895已完成不适用
Randomized, single-dose, parallel-arm, open-label Phase I trial to compare the pharmacokinetics, safety and tolerability of BI 695501 administered subcutaneously via prefilled syringe or autoinjector - Study comparing PK of BI 695501 between prefilled syringe and autoinjector
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
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
- 18 至 64（—）
入选标准
- •Healthy male or female subjects
- •Aged between 18 and 65 years (inclusive)
- •BMI of >17.5 to <35.0 kg/m2
排除标准
- •Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. Blood donation of more than 500 mL within 30 days prior to administration of trial medication or intended donation during the trial. Chronic or relevant acute infections. Previous exposure to adalimumab or proposed adalimumab biosimilar drugs. Subjects with any immunological disorders or auto-immune disorders, (e.g., RA, lupus erythematosus, scleroderma, etc.).
研究者
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