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| Name | Class |
|---|---|
| Quintiles, Inc. | INDUSTRY |
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Study to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) Zidebactam in healthy adult human subjects.
A double-blind, placebo-controlled study where healthy adult subjects will be randomly assigned to receive either of the investigational products (Zidebactam or placebo) in 2 multiple ascending dose (MAD) cohorts.
Primary Objective: to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) zidebactam in healthy adult human subjects.
Secondary Objective: to evaluate the pharmacokinetics (PK) of multiple escalating doses of IV zidebactam in healthy adult human subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: 3 g or 6 g of Zidebactam | Experimental | Cohort 1 (Zidebactam): 3 g of Zidebactam (1 g every 8 hours [q8h]) (n=8) IV infusions administered over 60 minutes. Cohort 2 (Zidebactam or placebo): 6 g of Zidebactam (2 g q8h) (n=8) IV infusions administered over 60 minutes. |
|
| Placebo | Placebo Comparator | Cohort 1: Placebo every 8 hours [q8h] (n=2) IV infusions administered over 60 minutes. Cohort 2: Placebo every q8h (n=2) IV infusions administered over 60 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 g or 6 g Zidebactam | Drug | IV for over a duration of 60 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability will be evaluated by reported AEs, clinical observations, vital signs measurements, and physical examination findings. | 14 days | |
| Safety and tolerability will be evaluated by 12-lead safety ECG results and clinical laboratory test results | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters -maximum plasma concentration will be evaluated. | 7 days | |
| Pharmacokinetic parameters- area under the plasma concentration-time curve from zero (pre-dose) to 8 hours will be evaluated. | 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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| ID | Term |
|---|---|
| C000624484 | zidebactam |
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| Placebo | Drug | IV matching the Investigational drug |
|
| Pharmacokinetic parameters- terminal half life etc will be evaluated | 7 days |