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The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08 after single i.v. infusion to the adult healthy volunteers. Additionally were assessed infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v. infusion and to explore TAB mechanism-of-action biomarkers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAB08 | Experimental | Single TAB08 i.v. infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAB08 | Biological | monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity in every dose cohort | From study drug infusion (Day 1) untill the end of study (Day 71/141) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga B Ershova, Prof. | Clinical Emergency Hospital of Yaroslavl | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Emergency Hospital of Yaroslavl | Yaroslavl | 150003 | Russia |
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| ID | Term |
|---|---|
| C509303 | TGN-1412 |
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