A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Healthy Male Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Maximum (peak) plasma concentration (Cmax)
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, double-blind, 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. A total of approximately 230 Chinese healthy male subjects are planned to be enrolled.
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
- •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.
- •Weight: 60~72kg; Body mass index (BMI) ≥ 19 and ≤ 26 kg /m² for healthy Chinese male subjects.
- •Fasting LDL-C level<4.1mmol/L.
- •Fasting triglycerides<3.42mmol/L.
- •Required to voluntarily adopt effective contraceptive measures as specified in the protocol throughout the entire trial period and within 3 months after receiving the investigational product, and avoid sperm donation.
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.
- •Investigators believe that other factors may disqualify individuals from participating in the trial.
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
Maximum (peak) plasma concentration (Cmax)
时间窗: Baseline till last follow-up visit (up to day 43)
Assess the Cmax of Ebronucimab.
Area under curve (AUC)
时间窗: Baseline till last follow-up visit (up to day 43)
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.
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.
次要结局
- Incidence of adverse events (AE)(After the first administration till last follow-up visit (up to day 43))
- Immunogenicity index(Baseline till last follow-up visit (up to day 43))
- Proprotein convertase subtilisin/kexin type 9 (PCSK-9) concentration(Baseline till last follow-up visit (up to day 43))
- Serum low-density lipoprotein cholesterol (LDL-C) concentration(Baseline till last follow-up visit (up to day 43))
- Incidence of adverse events (AE)(After the first administration till last follow-up visit (up to day 43 or day 57))
- Immunogenicity index(Day 1 and 43 ( or Day 57))
- Proprotein convertase subtilisin/kexin type 9 (PCSK-9) concentration(Day 1 and 43 ( or Day 57))
- Serum low-density lipoprotein cholesterol (LDL-C) concentration(Day 1 and 43 ( or Day 57))