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Phase I study to determine and compare the safety/tolerability of single ascending doses of POL6326 by intravenous infusion.
Phase I Study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POL6326 | Experimental | 2-hour single intravenous infusion doses of POL6326 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POL6326 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of single ascending doses of POL6326 by intravenous infusion according to standard criteria | Safety as measured by the incidence, type and severity of adverse events. | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic outcome | Determine the pharmacokinetic profile of POL6326 following single intravenous administration, e.g. Cmax, AUC, terminal half life and clearance | 24h |
| Mobilisation of CD34+ cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Halvard Boenig, M.D. Ph.D | German Red Cross Blood Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University, Frankfurt, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| German Red Cross Blood Service and Institute for Transfusion Medicine and Immunohematology of the Goethe University | Frankfurt | 60590 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28049490 | Derived | Karpova D, Brauninger S, Wiercinska E, Kramer A, Stock B, Graff J, Martin H, Wach A, Escot C, Douglas G, Romagnoli B, Chevalier E, Dembowski K, Hooftman L, Bonig H. Mobilization of hematopoietic stem cells with the novel CXCR4 antagonist POL6326 (balixafortide) in healthy volunteers-results of a dose escalation trial. J Transl Med. 2017 Jan 3;15(1):2. doi: 10.1186/s12967-016-1107-2. |
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| ID | Term |
|---|---|
| C000624271 | balixafortide |
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Time dependent measurement of CD34+ cells during and after infusion of POL6326 in all subjects
| 2 days |