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The purpose of this study is to evaluate the safety, tolerability, PK and immunogenicity of SV001 in patients with idiopathic pulmonary fibrosis.
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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 : Multiple-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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinfu Xu | Contact | 86-21-62483180 | hdyyll@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial People's Hospital | Recruiting | Chengdu | China |
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| Drug |
Placebo : Multiple-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 |
| The First Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | China |
|
| Hangzhou First People's Hospital | Recruiting | Hangzhou | China |
|
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
|
| Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School | Recruiting | Nanjing | China |
|
| The Affiliated Hospital of Inner Mongolia Medical University | Recruiting | Neimeng | China |
|
| Dongfang Hospital Affiliated to Tongji University | Recruiting | Shanghai | China |
|
| Huadong Hospital Affiliated to Fudan University | Recruiting | Shanghai | China |
|
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | China |
|
| General Hospital of Tianjin Medical University | Recruiting | Tianjin | China |
|
| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | China |
|
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | China |
|
| 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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