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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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Study to evaluate the safety, tolerability and pharmacokinetics of multiple escalating doses of intravenous WCK 5222 (Zidebactam and Cefepime) in healthy adult human subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 g of zidebactam (1 g q8h) and 6 g of cefepime (2 g q8h) or 6 | Active Comparator | administered as IV infusions every q8h, over a period of 60 minutes. |
|
| Placebo | Placebo Comparator | administered as IV infusions every q8h, over a period of 60 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous infusions of WCK 5222 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration | 7 days | |
| Time to Cmax | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles | Overland Park | Kansas | 66211 | United States |
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| Drug |
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