A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Chinese Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Area under curve (AUC)
研究概览
简要总结
This is a phase I clinical study to evaluate the pharmacokinetics (PK) similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects.
详细描述
This is a randomized, parallel controlled, phase I clinical study to evaluate the pharmacokinetics (PK) similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects. This study consists of two parts: pre-trial part and formal-trial part, with a planned enrollment of approximately 180 healthy male participants from China.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Weight: 60~80kg; Body mass index (BMI) ≥ 19 and ≤ 26 kg /m2 for healthy Chinese male subjects.
- •Subjects fully understand the purpose, content, process, and potential adverse events of the trial, voluntarily participate in the trial, and sign an informed consent form before any trial procedure begins.
- •Low density lipoprotein cholesterol (LDL-C) levels ≥ 1.8mmol/L and ≤ 4.9mmol/L during screening.
- •Subjects are able to communicate well with the investigator and understand the requirements of the study.
排除标准
- •12 months prior use of PCSK9 inhibitors treatment.
- •Allergic to the components of Ebronucimab and any monoclonal antibodies.
- •History of important organ transplantation (such as heart, lung, liver, kidney, etc.).
- •Abnormal vital signs during screening period and before randomization.
- •Drug abuse prior to screening.
研究组 & 干预措施
Ebronucimab 150mg (after the change)
Ebronucimab 150mg Single subcutaneous injection into the abdomen.
干预措施: Ebronucimab (Drug)
Ebronucimab 150mg (before the change)
Ebronucimab 150mg Single subcutaneous injection into the abdomen.
干预措施: Ebronucimab (Drug)
结局指标
主要结局
Area under curve (AUC)
时间窗: Baseline till last follow-up visit( up to day 43 or day 57)
Assess the AUC of Ebronucimab
Maximum (peak) plasma concentration (Cmax)
时间窗: Baseline till last follow-up visit( up to day 43 or day 57)
Assess the Cmax of Ebronucimab
Incidence of adverse events(AE)
时间窗: From the time of signing the informed consent form till last follow-up visit( up to day 43 or day 57)
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
次要结局
- Free protein convertase of proprotein convertase subtilisin/kexin type 9 (PCSK-9)(Baseline till last follow-up visit( up to day 43))
- Immunogenicity index(Day 1 and Day 57)
- PCSK-9 concentration(Day 1 and Day 57)
- Serum Low-density lipoprotein Cholesterol (LDL-C) concentration(Day 1 and Day 57)