NL-OMON51761已完成不适用
A Randomized, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetic Profile of REC-4881 in Healthy Volunteers - SAD and FE study to assess the safety, tolerability, PK and PD of REC-4881
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
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
- •1. Male or female participant aged 18 to 50 years, inclusive.
- •2. Participant must provide written informed consent.
- •3. Participant's body mass index is between 18 and 32 kg/m2, inclusive, with a
- •minimum body weight of 50 kg.
- •4. Participant is healthy, as determined by pre-study medical history,physical
- •examination (including neurologic examination), vital signs, and 12-lead ECG.
排除标准
- •1. Participant has any clinically significant laboratory abnormality or illness
- •which, in the opinion of the Investigator, could interfere with the conduct or
- •interpretation of the study or put the participant at risk.
- •2. Participant has a history of gall bladder disorder or complication,
- •including cholelithiasis.
- •3. Participant has a history of abnormal left ventricular ejection fraction.
- •4. Participant has a history of corneal erosions, corneal degenerations, active
- •or recurrent keratitis, and other forms of serious ocular surface inflammatory
- •conditions.
研究者
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