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

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

Inclusion Criteria:

• 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.

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.
• Investigators believe that other factors may disqualify individuals from participating in the trial.