NL-OMON53876已完成不适用
A comparative bioavailability study of a single dose of ziltivekimab formulation B in a manual syringe, formulation D in a manual syringe and formulation C in a pen-injector - Comparative bioavailability study of ziltivekimab formulation B, D and C
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
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
- •- Male or female
- •- Aged 18-64 years (both inclusive) at the time of signing informed consent.
- •- Body mass index (BMI) between 18.5 and 29.9 kg/m2 (both inclusive).
- •- Considered to be generally healthy based on the medical history, physical
- •examination, and
- •the results of vital signs, electrocardiogram and clinical laboratory tests
- •performed during
- •the screening visit, as judged by the investigator.
排除标准
- •- Known or suspected hypersensitivity to study intervention(s) or related
- •- Female who is pregnant, breast-feeding or intends to become pregnant or is of
- •childbearing
- •potential and not using adequate contraceptive method, as defined in section
- •- Any disorder which in the investigator*s opinion might jeopardise
- •participant*s safety or
- •compliance with the protocol.
- •- Use of prescription medicinal products or non-prescription drugs, except
- •routine vitamins,
- •topical medication, highly effective contraceptives and occasional use of
- •paracetamol,
- •acetylsalicylic acid within 14 days before trial product administration.
- •- Clinical evidence of, or suspicion of, active infection at the discretion of
- •the investigator.
研究者
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