EUCTR2019-000465-20-GB进行中（未招募）1 期
Safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple subcutaneous doses of NNC0365-3769 (Mim8) in healthy subjects and in subjects with haemophilia A with or without factor VIII inhibitors - FRONTIER1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 82
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Single ascending dose (SAD) part:
- •- Male, aged 18-45 years (both inclusive) at the time of signing informed consent
- •- 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
- •Multiple ascending dose (MAD) part:
- •- Male, aged 12-64 years (both inclusive) at the time of signing informed consent (Germany and Japan have local requirements)
- •- Diagnosis of congenital haemophilia A with FVIII activity <1% based on medical records
- •Exploratory biomarker cohort:
- •- Male, aged =12 years at the time of signing informed consent (Germany and Japan have local requirements)
- •- Diagnosis of congenital haemophilia A with FVIII activity <1% based on medical records
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 6
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •- Factor VIII activity =150% at screening
- •- Increased risk of thrombosis, e.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis
- •- Any clinical signs or established diagnosis of venous or arterial thromboembolic disease
- •- Known congenital or acquired coagulation disorders other than haemophilia A
- •- Increased risk of thrombosis as evaluated by the investigator. E.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
- •- Any clinical signs or established diagnosis of venous or arterial thromboembolic disease with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
- •- Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke) as evaluated by the investigator
- •- Any autoimmune disease that may increase the risk of thrombosis
- •- Receipt of emicizumab or drugs with similar modes of action within 5 half-lives before trial product administration
- •- Ongoing or planned immune tolerance induction therapy
- •Exploratory biomarker cohort:
- •- Known congenital or acquired coagulation disorders other than haemophilia A
- •- Increased risk of thrombosis as evaluated by the investigator. E.g. known history of personal or first degree relative(s) with unprovoked deep vein thrombosis with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
- •- Any clinical signs or established diagnosis of venous or arterial thromboembolic disease with exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing
- •- Advanced atherosclerotic disease (e.g. known history of ischemic heart disease, ischemic stroke) as evaluated by the investigator
- •- Any autoimmune disease that may increase the risk of thrombosis
- •- Ongoing or planned immune tolerance induction therapy
研究者
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