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The purpose of this study is to evaluate safety, tolerability, PK and immunogenicity of SV001 compare to placebo in Chinese healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SV001 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SV001 | Drug | SV001 : single-dose |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Adverse event type, incidence, duration | Approximately 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | PK (Pharmacokinetics) | Approximately 1 years |
| Peak time(Tmax) | PK (Pharmacokinetics) | Approximately 1 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui District Central Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Drug |
Placebo : single-dose |
|
| Area under the plasma concentration versus time curve (AUC) | PK (Pharmacokinetics) | Approximately 1 years |
| half-life(T1/2) | PK (Pharmacokinetics) | Approximately 1 years |
| Immunogenicity | ADA(Anti-drug antibody) | Approximately 1 years |