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The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SV003 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SV003 | Drug | SV003:Single-dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Adverse event type, incidence, duration | Approximately 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | PK (Pharmacokinetics) | Approximately 3 months |
| Peak time(Tmax) | PK (Pharmacokinetics) | Approximately 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Chen | Contact | 86-021-36682212 | xhzxyy@xh.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Recruiting | Shanghai | 200237 | China |
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| Drug |
Placebo : Single-dose |
|
| Area under the plasma concentration versus time curve (AUC) | PK (Pharmacokinetics) | Approximately 3 months |
| half-life(T1/2) | PK (Pharmacokinetics) | Approximately 3 months |
| Immunogenicity | ADA(Anti-drug antibody) | Approximately 3 months |