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TG-0054 is a CXCR4 antagonist with stem cell mobilization effect as proven in animal model, this is the fist in human study to investigator the safety, tolerability and PK/PD in healthy subjects.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TG-0054 | Drug | 0.10, 0.14, 0.28, 0.56, 1.12, 2.24, 3.14, and 4.40 mg/kg of TG-0054/placebo via 15 min IV infusion |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability for a single IV dose of TG-0054 | ||
| To determine the maximum tolerated dose (MTD) of TG-0054 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the plasma pharmacokinetics (PK) profile of TG-0054 | ||
| To assess the pharmacodynamic (PD) effects of TG-0054 via CD34+stem cell, CD133+ progenitor cell counts; white blood cell (WBC), red blood cell (RBC), platelet, and differential counts |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald Goldwater, M.D. | PAREXEL Clinical Pharmacology Research Unit Harbor Hospital Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL Clinical Pharmacology Research Unit Harbor Hospital Center | Baltimore | Maryland | 21225 | United States |
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