Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Dose of Reformulated NNC0365-3769 (Mim8) in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Number of treatment-emergent adverse events
研究概览
简要总结
NN0365-3769 (Mim8) is a study medicine with the potential to prevent and reduce bleeding in people with haemophilia A (an inherited disorder in which blood does not coagulate properly).
This study will investigate if different doses of Mim8 are safe, and also check how Mim8 behaves in the body.
Twelve different doses will be tested. Participants will only get one of the doses. Which dose participants get is decided by chance. Participants will get a single injection under the skin of the belly by means of a syringe and a needle.
The study will last for about 17 - 21 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male, aged 18-55 years (both inclusive) at the time of signing informed consent
- •Body mass index between 18.5 and 29.9 kg/m^2 (both inclusive)
- •Body weight between 60.0 to 100.0 kg (both inclusive)
- •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.
排除标准
- •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
- •Factor VIII activity greater than or equal to150% at screening
- •Any of the thrombophilia markers listed below:
- •Protein C, protein S or antithrombin below the lower normal laboratory range
- •Factor II activity, activated protein C resistance, lupus anticoagulant, anti-cardiolipin antibody (IgG and IgM) or anti-β2 glycoprotein I antibody (IgG and IgM) outside the normal laboratory range at screening
研究组 & 干预措施
Dose level 1
All participants will receive a single dose of Mim8
干预措施: Mim8 B, 10 mg/mL (Drug)
Dose level 1
All participants will receive a single dose of Mim8
干预措施: Mim8 B, placebo (Drug)
Dose level 2
All participants will receive a single dose of Mim8
干预措施: Mim8 B, 10 mg/mL (Drug)
Dose level 3
All participants will receive a single dose of Mim8
干预措施: Mim8 B, 100 mg/mL (Drug)
Dose level 3
All participants will receive a single dose of Mim8
干预措施: Mim8 B, placebo (Drug)
Dose level 4
All participants will receive a single dose of Mim8
干预措施: Mim8 B, 10 mg/mL (Drug)
Dose level 5
All participants will receive a single dose of Mim8
干预措施: Mim8 B, 100 mg/mL (Drug)
Dose level 5
All participants will receive a single dose of Mim8
干预措施: Mim8 B, placebo (Drug)
Dose level 6
All participants will receive a single dose of Mim8
干预措施: Mim8 B, 10 mg/mL (Drug)
Dose level 7
All participants will receive a single dose of Mim8
干预措施: Mim8 B, 100 mg/mL (Drug)
Dose level 8
All participants will receive a single dose of Mim8
干预措施: Mim8 B, 100 mg/mL (Drug)
Dose level 8
All participants will receive a single dose of Mim8
干预措施: Mim8 B, placebo (Drug)
Dose level 9
All participants will receive a single dose of Mim8
干预措施: Mim8 B, 100 mg/mL (Drug)
Dose level 9
All participants will receive a single dose of Mim8
干预措施: Mim8 B, placebo (Drug)
Dose level 10
All participants will receive a single dose of Mim8
干预措施: Mim8 B, 100 mg/mL (Drug)
Dose level 11
All participants will receive a single dose of Mim8
干预措施: Mim8 B, 100 mg/mL (Drug)
Dose level 11
All participants will receive a single dose of Mim8
干预措施: Mim8 B, placebo (Drug)
Dose level 12
All participants will receive a single dose of Mim8
干预措施: Mim8 B, 100 mg/mL (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 day 113
Count
次要结局
- AUC0-inf, SD: the area under the Mim8 concentration-time curve from time 0 to infinity after a single dose(From time of dosing (day 1) to day 113)
- Change in activated partial thromboplastin time(From baseline (day 1) to day 113)
- Number of injection site reactions(From time of dosing (day 1) to day 113)
- Cmax, SD: the maximum concentration of Mim8 after a single dose(From time of dosing (day 1) to day 113)
- tmax, SD: the time to maximum concentration of Mim8 after a single dose(From time of dosing (day 1) to day 113)
- t1/2, SD: the terminal half-life of Mim8 after a single dose(From time of dosing (day 1) to day 113)