CompletedPhase 1

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

China230 participantsStarted 2025-10-20

Plain-language summary

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.

Who can participate

Age range

18 Years – 45 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum (peak) plasma concentration (Cmax)

Timeframe: Baseline till last follow-up visit (up to day 43)

Area under curve (AUC)

Timeframe: Baseline till last follow-up visit (up to day 43)

Trial details

NCT IDNCT07043283

SponsorAkeso

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-07

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