NL-OMON49427已完成不适用
Single dose escalation study in a single-center, randomized, single-blind, placebo-controlled, group-comparison design to investigate pharmacokinetics, safety and tolerability of BAY 2586116 after intravenous administration in healthy male participants. - Intravenous single dose escalation study of BAY 2586116.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer AG
- 入组人数
- 35
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
- •Participant must be 18 to 45 years of age inclusive, at the time of signing the
- •informed consent.
- •Participants who are overtly healthy as determined by medical evaluation
- •(including medical and surgical history, physical examination,laboratory tests,
- •ECG, vital signs, and pulse oximetry). Re-screening may be allowed.
- •Race: White (Note: Clinical Data Interchange Standards Consortium definition of
- •White: Denotes a person with European, Middle Eastern, or North African
- •ancestral origin who identifies, or is identified, as White (Food and Drug
- •Administration).
- •Male participant.
排除标准
- •Medical disorder, condition or history of such that would impair the
- •participant's ability to take part in or complete this study in the opinion of
- •the investigator
- •A history of relevant diseases of vital organs, of the central nervous system
- •or other organs
- •Pre-existing diseases for which it can be assumed that the absorption,
- •distribution, metabolism, elimination and effects of the study intervention
- •will not be normal.
- •Regular use of medicines.
- •Positive SARS-CoV-2 viral RNA test.
研究者
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