drugset / Trial / NCT00822978
Phase 1 Study for Safety of ACHN-490
RandomizedParallel-groupQuadruple-blind
Summary
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.
Timeline
- Start
- 2009-01
- Primary completion
- 2009-10
- Completion
- 2009-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | plazomicin | Small molecule | 4 mg/kg | Intravenous |
| Comparator | plazomicin | Small molecule | 15 mg/kg | Intravenous |
Indications
No indication recorded.