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| ID | Type | Description | Link |
|---|---|---|---|
| DMID 16-0014 | Other Identifier | DMID | |
| 272201300019C-3-0-1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VNRX-5133 | Experimental | IV infusion |
|
| Placebo | Placebo Comparator | IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VNRX-5133 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events; assessed by patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis. | Part 1: 8 days. Part 2: 17 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lenexa | Kansas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34370573 | Derived | Dowell JA, Dickerson D, Henkel T. Safety and Pharmacokinetics in Human Volunteers of Taniborbactam (VNRX-5133), a Novel Intravenous beta-Lactamase Inhibitor. Antimicrob Agents Chemother. 2021 Oct 18;65(11):e0105321. doi: 10.1128/AAC.01053-21. Epub 2021 Aug 9. |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000707821 | taniborbactam |
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