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The complement system is an important component of the innate immune system. Abnormal activation, inadequate regulation and control of the complement system, as well as impaired and dysfunctional effector functions, underlie complement mediated diseases. VSA012 targeting complement system has the potential to treat a variety of diseases associated with abnormal activation of the complement system (e.g. PNH) .The purpose of VSA012-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of VSA012 Injection in adult healthy volunteers (HVs). HVs will receive a single dose of VSA012 or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort1 | Experimental |
| |
| Cohort2 | Experimental |
| |
| cohort3 | Experimental |
| |
| Cohort4 | Experimental |
| |
| cohort5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VSA012 | Drug | VSA012 injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs) | up to Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of VSA012: Maximum Observed Plasma Concentration (Cmax) | Up to 48 hours post-dose | |
| PK of VSA012: Time to Maximum Observed Plasma Concentration (Tmax) | Up to 48 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | China |
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| Placebo | Drug | Placebo |
|
| PK of VSA012: Area Under the Plasma Concentration Versus Time Curve | Up to 48 hours post-dose |
| Change from Baseline in Serum Complement Factor B (CFB) | Up to Day 180 |
| Change from Baseline in Serum Complement Alternative Pathway (CAP) | up to Day 180 |
| The incidence of ADA | up to Day 180 |