NL-OMON55239已完成不适用
A phase 1, randomized, double-blind, placebo-controlled, safety, tolerability, pharmacokinetic and biomarker study of multiple ascending doses of ESB1609 in healthy volunteers. - CS0340 ESCAPE 190526
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
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
- •Part 1 Subject Inclusion Criteria
- •1. The subject has provided written informed consent.
- •2. The subject is a male 18 to 55 years of age (inclusive at screening)
- •3. For Cohort 3 B only the subject is a male aged 55-65 years of age
排除标准
- •Part 1 Subject Exclusion Criteria
- •1. The subject has a current or recurrent disease (e.g., cardiovascular, renal,
- •liver, gastrointestinal, malignancy or other conditions) that could affect the
- •action, absorption or disposition of the investigational product or could
- •affect clinical or laboratory assessments.
- •2. The subject has a clinically significant 12-lead ECG abnormality, including
- •QTc of >450 msec (average of triplicate measures via Fridericia*s corrections)
- •for any Screening or Day -1 ECG assessment.
- •3. The subject has a history of clinically significant bradycardia syndromes
- •(e.g., sick sinus syndrome) or sinus bradycardia at Screening or Day -1.
研究者
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