A Study to Demonstrate Bioequivalence of a Single Subcutaneous Administration of NNC0365-3769 (Mim8) With the DV3407-C1 Pen Injector Versus a Syringe and Enhanced Cartridge in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- AUC0-112 days, SD: area under the Mim8 plasma concentration-time curve from time 0 until 112 days after a single dose
研究概览
简要总结
Novo Nordisk is developing the study medicine Mim8 for the treatment of haemophilia A. The study aims to show similar levels of Mim8 in blood when using a new pen injector, called DV3407-C1 pen injector, and when using a syringe and cartridge. The new pen injector is intended to facilitate the administration of Mim8 for patients with haemophilia A. The participants will get Mim8 as injection under the skin (subcutaneously) of the belly using the DV3407-C1 pen injector and a needle (hereinafter referred to as pen injector) or using a needle and syringe from a cartridge (hereafter called syringe and cartridge). The participants will receive one injection with Mim8, either with the DV3407-C1 pen injector or with a syringe and cartridge. The study participation will last up to 20 weeks. Only healthy men can take part in the study.
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)
盲法说明
The study consists of two parts - an open-label pilot part and a double-blind bioequivalence part.
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 (BMI) between 18.5 and 29.9 kilogram per square metre (kg/m^2) (both inclusive) at screening.
- •Body weight between 60.0 and 100.0 kg (both inclusive) at screening.
- •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 to (≥) 150 percent (%) at screening.
- •Thrombophilia as identified by any of the below laboratory markers at screening:
- •Protein C, protein S or antithrombin less than (<) lower limit of normal (LLN)
- •Factor II activity or activated protein C resistance >upper limit of normal (ULN).
研究组 & 干预措施
Arm 1 (Pilot part)
Participants will receive a single dose of Mim8 using a 32G, 4 mm pen-needle with the DV3407-C1 pen injector.
干预措施: NNC0365-3769 (Mim8) (Drug)
Arm 2 (Pilot part)
Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge.
干预措施: NNC0365-3769 (Mim8) (Drug)
Arm 3 (Bioequivalence part)
Participants will receive a single dose of Mim8 using a 29G, 4 mm pen-needle with the DV3407-C1 pen injector.
干预措施: NNC0365-3769 (Mim8) (Drug)
Arm 4 (Bioequivalence part)
Participants will receive a single dose of Mim8 using a 29G, 8 mm needle and syringe with the enhanced cartridge.
干预措施: NNC0365-3769 (Mim8) (Drug)
结局指标
主要结局
AUC0-112 days, SD: area under the Mim8 plasma concentration-time curve from time 0 until 112 days after a single dose
时间窗: From time of dosing (day 1) to day 113
Measured in micrograms\*day per milliliter (μg\*day/mL).
Cmax, SD: maximum plasma concentration of Mim8 after a single dose
时间窗: From time of dosing (day 1) to day 113
Measured in μg/mL.
次要结局
- 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)
- Number of injection site reactions(From time of dosing (day 1) to day 113)
- AUC0-inf, SD: area under the Mim8 plasma concentration-time curve from time 0 to infinity after a single(From time of dosing (day 1) to day 113)