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| Name | Class |
|---|---|
| Beijing VDJBio Co., LTD. | INDUSTRY |
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The goal of this clinical trial is to study the tolerability, safety, pharmacokinetics and immunogenicity of investigational drug in healthy subjects. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A single intravenous administration of 1mg VDJ001 or placebo | Experimental | Drug: VDJ001 Drug: Placebo |
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| A single intravenous administration of 2mg VDJ001 or placebo | Experimental | Drug: VDJ001 Drug: Placebo |
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| A single intravenous administration of 4mg VDJ001 or placebo | Experimental | Drug: VDJ001 Drug: Placebo |
|
| A single intravenous administration of 8mg VDJ001 or placebo | Experimental | Drug: VDJ001 Drug: Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VDJ001 | Drug | a novel recombinant humanized anti-interleukin-6 receptor monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | Incidence, severity and relation to investigational drugs of adverse events | up to 57 days |
| Pharmacokinetics-AUC0-t | area under the concentration-time curve (AUC) from administration to the last measurable concentration | up to 57 days |
| Pharmacokinetics-AUC0-inf | AUC extrapolated to infinity | up to 57 days |
| Pharmacokinetics-Cmax | maximum serum concentration | up to 57 days |
| Pharmacokinetics-Tmax | time to Cmax | up to 57 days |
| Pharmacokinetics-t1/2 | elimination half-life | up to 57 days |
| Pharmacokinetics-Vz | volume of distribution | up to 57 days |
| Pharmacokinetics-CLz | clearance rate | up to 57 days |
| Pharmacokinetics- λz | elimination rate constant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu Cao | The Affiliated Hospital of Qingdao University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Affliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
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| Placebo | Drug | Placebo |
|
| up to 57 days |
| Pharmacokinetics-MRT0-t | mean residence time (MRT) from administration to the last measurable concentration (MRT0-t) | up to 57 days |
| Pharmacokinetics-MRT0-inf | MRT extrapolated to infinity | up to 57 days |
| Anti-Drug antibody (ADA) | Percentage of subjects tested ADA positive. | up to 57 days |
| Neutralizing antibodies (Nab) | Percentage of subjects tested Nab positive. | up to 57 days |