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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, 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.
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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 |
|---|---|---|
| Area under curve (AUC) | Assess the AUC of Ebronucimab | Baseline till last follow-up visit( up to day 43 or day 57) |
| Maximum (peak) plasma concentration (Cmax) | Assess the Cmax of Ebronucimab | 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. | From the time of signing the informed consent form till last follow-up visit( up to day 43 or day 57) |
| Measure | Description | Time Frame |
|---|---|---|
| Free protein convertase of proprotein convertase subtilisin/kexin type 9 (PCSK-9) | Concentration and percentage change from baseline of free protein convertase PCSK-9 | Baseline till last follow-up visit( up to day 43) |
| Immunogenicity index |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guoqin Wang | Contact | +86 (0760) 8987 3999 | global.trials@akesobio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
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| Ebronucimab |
| Drug |
Ebronucimab subcutaneous injection |
|
Number and percentage of subjects with detectable anti drug antibodies (ADA) and neutralizing antibodies (Nab) after treatment.
| Day 1 and Day 57 |
| PCSK-9 concentration | Percentage change in PCSK-9 concentration compared to baseline | 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 | Day 1 and Day 57 |