NL-OMON44302已完成2 期
Double-blinded, randomised, placebo-controlled, multicentre , Phase IIa study to investigate the effect, safety and tolerability of phosphorylcholine human monoclonal antibody (PC-mAb) 3G10 on arterial inflammation, together with safety and tolerability, in subjects with elevated lipoprotein a (Lp[a ]) - ATH-3G10-005
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
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. Provision of a signed written informed consent
- •2. Lp(a) above 50 mg/dL at screening
- •3. Male or female, >= 50 years of age at screening
排除标准
- •1. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the result or the subject*s ability to participate in the study
- •2. Illness (including common colds) for the last 4 weeks before screening
- •3. Medical history of myocardial infarction (MI) or stroke within 12 months of screening
- •4. Ongoing or paroxysmal atrial fibrillation
- •5. Clinically overt heart failure
- •6. Hypertension defined as >=180/100 mmHg
- •7. Diabetes mellitus
研究者
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