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This is a first-in-human phase 1 study to assess if ACHN-490 Injection is safe in people. Groups of people will receive either the study medication (ACHN-490) or a placebo (normal saline) as a single infusion. If the single dose is well tolerated then this group will receive 1 dose per day for up to 10 consecutive days. A new group of people will receive the study medication at a higher dose than the previous dose level as long as the previous dose was safe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACHN-490 Injection | Active Comparator | ACHN-490 Injection in escalating doses |
|
| 2 | Placebo Comparator | Placebo is normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACHN-490 Injection vs placebo | Drug | Escalating doses beginning with test dose given once, followed by 4 mg/kg with a single dose then multiple dose. Dose escalation to continue up to 15 mg/kg as long as the treatment is deemed safe. |
| Measure | Description | Time Frame |
|---|---|---|
| Incident and severity of adverse events | 2 weeks after the last dose for each dose group |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in kidney function, laboratory values, abd vital signs | single and multi-dose | |
| Pharmacokinetic parameters | After single and multiple-dose administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carter Brooks, MD | Jasper Clinic, Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jasper Clinic | Kalamazoo | Michigan | 49007 | United States |
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