NL-OMON41013已完成不适用
A Randomized, Double Blind, Single Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of ONS-3010 (Adalimumab, Oncobiologics, Inc.) Compared to Two Reference Products of Humira® (Abbvie) in Healthy Adult Subjects - Single dose study of ONS 3010 in healthy volunteers
Oncobiologics Inc.0 个研究点目标入组 180 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 180
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 99(—)
入选标准
- •Healthy male or female volunteers, 18-55 years of age, willing and able to provide written informed consent.
排除标准
- •Diagnosis of tuberculosis or risk factors for (latent) tuberculosis; recent or planned vaccinations; recent infections, chronic infections, history of severe infections, or impaired immunity; dysplasia or malignancy; auto-immune disorder, demyelinating disease, or any other condition which, in the opinion of the investigator, would put the subject at risk.
研究者
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