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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Ebronucimab subcutaneous injection
Ebronucimab subcutaneous injection
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Area under curve (AUC)
Assess the AUC of Ebronucimab
Time frame: Baseline till last follow-up visit( up to day 43 or day 57)
Maximum (peak) plasma concentration (Cmax)
Assess the Cmax of Ebronucimab
Time frame: Baseline till last follow-up visit( up to day 43 or day 57)
Incidence of adverse events(AE)
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.
Time frame: From the time of signing the informed consent form till last follow-up visit( up to day 43 or day 57)
Free protein convertase of proprotein convertase subtilisin/kexin type 9 (PCSK-9)
Concentration and percentage change from baseline of free protein convertase PCSK-9
Time frame: Baseline till last follow-up visit( up to day 43)
Immunogenicity index
Number and percentage of subjects with detectable anti drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.
Time frame: Day 1 and Day 57
PCSK-9 concentration
Percentage change in PCSK-9 concentration compared to baseline
Time frame: Day 1 and Day 57
Serum Low-density lipoprotein Cholesterol (LDL-C) concentration
The change value and percentage of serum LDL-C concentration compared to baseline
Time frame: Day 1 and Day 57
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