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This trial is conducted in China. The purpose of this study is to evaluate the pharmacokinetic similarity of Tafolecimab with different manufacturing process in healthy male subjects. Another purpose is to determine safety, and immunogenicity of sintilimab with different manufacturing process,also to determine Pharmacodynamics of Tafolecimab with different manufacturing process
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tafolecimab (a modified manufacturing process) | Experimental | 450mg,SC,single dose |
|
| tafolecimab (a original manufacturing process) | Active Comparator | 450mg,SC,single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tafolecimab (a modified manufacturing process) | Drug | 450mg,SC,single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence results using the peak serum drug concentration (Cmax) as the judging indicators | up to Day 57 | |
| Bioequivalence results using the area under the serum concentration-time curve (AUC0-inf) as the judging indicators | up to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Other PK parameters: Area under the plasma concentration-time curve (AUClast) | up to Day 57 | |
| Other PK parameters: Volume of distribution (V) | up to Day 57 | |
| Other PK parameters: elimination half-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aerospace Center Hospital | Beijing | China |
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| tafolecimab (a original manufacturing process) | Drug | 450mg,SC,single dose |
|
|
| up to Day 57 |
| Number of participants with adverse events, with abnormal vital signs, abnormal physical examination, abnormal laboratory test results and abnormal ECG readings | up to Day 57 |
| The occurrence of Anti-drug Antibody(ADA) | up to Day 57 |
| The occurrence of Neutralizing antibodies Antibody(NAb) | up to Day 57 |
| Percentage Change from baseline in Low Density Lipoprotein choleterol (LDL-C) | up to Day 57 |
| Percentage Change from baseline in Proprotein convertase subtilisin/kexin type 9(PCSK-9) | up to Day 57 |