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Multiple center, double-blind, randomized, placebo-controlled study to see if it is safe to give ACHN-490 Injection for 5 consecutive days, to measure plasma pharmacokinetics, and to determine lung penetration of ACHN-490 (measured in ELF-epithelial lining fluid)after a single dose of ACHN-490 Injection in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACHN-490 Injection | Active Comparator | ACHN-490 Injection will be given either 1 or 5 consecutive days at a dose of 15mg/kg. |
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| Placebo is Normal Saline | Placebo Comparator | Placebo will be given either 1 or 5 consecutive days to mask when ACHN-490 Injection is given. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACHN-490 Injection | Drug | ACHN-490 Injection at 15mg/kg is given either 1 or 5 consecutive days. Cohort 1 receives 5 consecutive days of treatment and Cohort 2 receives a single dose of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by reported adverse events after administering ACHN-490 Injection/placebo for 5 consecutive days | Throughout the study |
| Measure | Description | Time Frame |
|---|---|---|
| Lung penetration as estimated from ACHN-490 measured in ELF | 1 Day | |
| Plasma pharmacokinetic profile as measured by the concentration of ACHN-490 in the blood after 5 days of dosing | Through 24 hours after the last dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy A Havrilla, MS, RN | Achaogen, Inc. | Study Director |
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| ID | Term |
|---|---|
| C550938 | plazomicin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Placebo (normal saline) | Drug | Placebo is given at the same volume as ACHN-490 Injection to maintain the blind. |
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