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| Name | Class |
|---|---|
| Celerion | INDUSTRY |
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The purpose of this study is to evaluate safety and pharmacokinetics of single ascending IV doses of GMI-1359 in healthy adult subjects.
This is a randomized, double-blind, placebo-controlled, single ascending IV dose study conducted at one study center in the United States. Safety will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of GMI-1359.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GMI-1359 | Experimental | Dose escalation |
|
| Placebo | Experimental | Dose escalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GMI-1359 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related adverse events | Treatment related adverse events as a measure of safety and tolerability of GMI-1359 | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics | Cmax (peak plasma concentration) | 48 hours |
| Pharmacokinetics | AUC (area under the curve) | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laura Sterling, MD | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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|
| Pharmacokinetics | Tmax (time to peak plasma concentration) | 48 hours |
| Pharmacodynamics | CD34 cell measurement | 48 hours |