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The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of single ascending IV doses of GMI-1271 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 (US). One (1) cohort of 12 subjects (6 active and 6 placebo) and two (2) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation. Subjects will participate in only one cohort. Safety will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and PK assessment of GMI-1271.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 2 mg/kg GMI-1271 or matching placebo |
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| Cohort 2 | Experimental | 5 mg/kg GMI-1271 or matching placebo |
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| Cohort 3 | Experimental | 10 mg/kg GMI-1271 or matching placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GMI-1271 | Drug | GMI-1271 is a potent, rationally designed glycomimetic E-selectin antagonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related adverse events | Treatment related adverse events as a measure of safety and tolerability of GMI-1271 (time frame: Day 1-15) | Day 1-15 |
| Measure | Description | Time Frame |
|---|---|---|
| Time of peak plasma concentration (Tmax) | Day 1-3 | |
| Pharmacodynamics | WBC count, biomarkers to assess pharmacodynamics of single IV dose of GMI-1271 (time frame: Day 1-3) | Day 1-3 |
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Inclusion Criteria:
Exclusion Criteria:
Note: If an increase (>1.5 x N) in bilirubin is present at screening additional liver function tests may be performed (such as ALT, AST, ALP, albumin, and direct and indirect bilirubin) to determine if the increase of bilirubin is due to Gilbert-Meulengracht syndrome. If consistent with Gilbert's syndrome, the Investigator and Sponsor may decide not to consider this as an exclusion. Any such decision will be documented in the study record.
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Cook, MD | Celerion | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion | Lincoln | Nebraska | 68502 | United States |
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| ID | Term |
|---|---|
| C000654285 | uproleselan |
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| Placebo | Drug |
|
| Peak plasma concentration (Cmax) | Day 1-3 |
| Area under the plasma concentration vs time curve (AUC) | Day 1-3 |