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| ID | Type | Description | Link |
|---|---|---|---|
| C3501001 | Other Identifier | Alias Study Number |
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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic profile of an antibacterial compound for treatment of hospital acquired Gram negative infection.
Single-center, randomized, placebo-controlled, double-blind study to determine the safety, tolerability and pharmacokinetic profile of compound in single and multiple doses in young healthy males.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AN3365 | Active Comparator |
| |
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AN3365 | Drug | LP, 600 mg vial; reconstituted in Normal Saline |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical safety data from 12-lead ECG, clinical laboratory tests, urinalysis, injection site tolerability, spontaneous/elicited adverse event reporting, and vital signs (blood pressure, heart rate, respiratory rate) | Multiple time points up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pharmacokinetic parameters to achieve appropriate exposure and estimate the dose proportionality | Multiple time points up to 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX | Adelaide | Australia |
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| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D007239 | Infections |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| Placebo |
| Drug |
0.9% sodium chloride for injection |
|