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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ebronucimab 150mg (after the change) | Experimental | Ebronucimab 150mg Single subcutaneous injection into the abdomen. |
|
| Ebronucimab 150mg (before the change) | Experimental | Ebronucimab 150mg Single subcutaneous injection into the abdomen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ebronucimab | Drug | Ebronucimab subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum (peak) plasma concentration (Cmax) | Assess the Cmax of Ebronucimab. | Baseline till last follow-up visit (up to day 43) |
| Area under curve (AUC) | Assess the AUC of Ebronucimab. | Baseline till last follow-up visit (up to day 43) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After the first administration till last follow-up visit (up to day 43) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Xiaoshan Hospital | Hangzhou | Zhejiang | China |
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| Immunogenicity index |
Number and percentage of subjects with detectable anti drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment. |
| Baseline till last follow-up visit (up to day 43) |
| Proprotein convertase subtilisin/kexin type 9 (PCSK-9) concentration | Percentage change in PCSK-9 concentration compared to baseline. | Baseline till last follow-up visit (up to day 43) |
| Serum low-density lipoprotein cholesterol (LDL-C) concentration | The change value and percentage of serum LDL-C concentration compared to baseline. | Baseline till last follow-up visit (up to day 43) |