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The purpose of the study is to evaluate safety and tolerability of 4SC-203 after a single dose administration in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4SC-203 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4SC-203 | Drug | i.v. administration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Investigation of safety and tolerability of escalating single doses of 4SC-203. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the pharmacokinetics of single doses of 4SC-203. | 14 days | |
| To assess the pharmacodynamic effect by means of appropriate biomarkers. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Wagner, PD Dr. med. | Charité Research Organisation GmbH, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité Research Organisation | Berlin | Germany |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Drug |
i.v. administration |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |