NCT07220564招募中1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Peroral Doses of Inno8 in People With Haemophilia A
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 64
- 主要终点
- Number of treatment emergent adverse events
研究概览
简要总结
This study will test how different doses of study medicine (Inno8) work in the bodies of people with haemophilia A. The purpose of the study is to see if Inno8 is safe to use for people with haemophilia A. The study medicine is a new medicine that cannot yet be prescribed by doctors. The study will last for about 11 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-64 years (both inclusive) at the time of signing the informed consent.
- •Body weight greater than or equal to (≥) 45 kilograms (kgs).
- •Diagnosis of congenital haemophilia A with factor VIII (FVIII) activity less than or equal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medical records.
排除标准
- •Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening.
- •Body mass index ≥30.0 kilogram per square meter (kg/m^2).
- •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.
- •Any known coagulation disorders other than haemophilia A.
- •Ongoing or planned immune tolerance induction therapy.
- •Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
研究组 & 干预措施
Cohort 3
Experimental
Participants will receive oral dose of NNC0442-0344 A.
干预措施: NNC0442-0344 A (Drug)
Cohort 1
Experimental
Participants will receive oral dose of NNC0442-0344 A.
干预措施: NNC0442-0344 A (Drug)
Cohort 2
Experimental
Participants will receive oral dose of NNC0442-0344 A.
干预措施: NNC0442-0344 A (Drug)
结局指标
主要结局
Number of treatment emergent adverse events
时间窗: From time of dosing (Day 1) to end of follow-up (Day 46)
Measured as count of events.
次要结局
- Change in D-dimer(From time of dosing (Day 1) to end of follow-up (Day 46))
- Change in prothrombin fragment 1 and 2(From time of dosing (Day 1) to end of follow-up (Day 46))
- Change in fibrinogen(From time of dosing (Day 1) to end of follow-up (Day 46))
- Change in platelets(From time of dosing (Day 1) to end of follow-up (Day 46))
- Occurrence of anti-Inno8 antibodies(From time of dosing (Day 1) to end of follow-up (Day 46))
- Cmax: the maximum concentration of Inno8 after multiple doses(From Day 10 to Day 11)
- Tmax: the time to Cmax after last multiple dose(From day 10 to Day 11)
- Tmax: the time to Cmax after first dose(From Day 1 to Day 2)
- AUC: the area under the Inno8 concentration-time curve in the dosing interval after multiple doses(From Day 10 to Day 11)
- Maximum thrombin generation (peak height)(From Day 10 to Day 11)
研究者
研究点 (64)
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