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.
Eligibility
Sex
MALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Area under curve (AUC) — Baseline till last follow-up visit( up to day 43 or day 57) Assess the AUC of Ebronucimab
Maximum (peak) plasma concentration (Cmax) — Baseline till last follow-up visit( up to day 43 or day 57) Assess the Cmax of Ebronucimab
Incidence of adverse events(AE) — From the time of signing the informed consent form till last follow-up visit( up to day 43 or day 57) An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Trial sites (1)
Facility
City
Region
Status
The Third Xiangya Hospital of Central South University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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