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This is a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, pharmacokinetics, and pharmacodynamics of WAL0921 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WAL0921 | Experimental | Single intravenous infusion of investigational drug WAL0921 |
|
| Placebo | Placebo Comparator | Single intravenous infusion of normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WAL0921 | Drug | Investigational product WAL0921 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment emergent adverse events | Day 1 to Day 64 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with clinically significant changes in hematology lab values | Hematology labs include complete blood count with differential and coagulation panel | Day 64 |
| Number of participants with clinically significant changes in chemistry lab values |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Blair, MD | Walden Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Pharmacology Unit | Austin | Texas | 78744 | United States |
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| Drug |
Placebo product |
|
Chemistry labs include a comprehensive metabolic panel |
| Day 64 |
| AUC | Area Under the Drug Concentration-Time Curve | Day 1 to Day 64 |
| Cmax | Maximum Observed Drug Concentration | Day 1 to Day 64 |
| Half-life | Drug terminal elimination half-life | Day 1 to Day 64 |