A Study Evaluating the Single Subcutaneous Injection of Ebronucimab in Chinese Healthy Male Subjects

A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Chinese Healthy Male Subjects

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.

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.

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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.