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

Launched by AKESO · Jun 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called Ebronucimab, given as a single injection under the skin, to see how it behaves in the body of healthy Chinese men. The main goal is to check if the medicine made using different production methods works in a similar way. This is an early-stage study, which means it is mainly focused on safety and how the body processes the medicine.

Men who want to join need to be between 18 and 45 years old, weigh between 60 and 80 kilograms (about 132 to 176 pounds), and have a healthy body weight based on their height. They should have normal cholesterol and fat levels in their blood and must agree to use effective birth control during the study and for three months after. Participants will be asked to carefully read and sign a consent form to make sure they understand the study. People who have used similar cholesterol-lowering drugs recently, have allergies to this type of medicine, or have had major organ transplants won’t be allowed to join. If you take part, you can expect to receive one injection and have your health closely monitored to make sure the medicine is safe and works as expected.

Gender

MALE

Eligibility criteria

• 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\~80kg; 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.