drugset / Trial / NCT01034774

Phase 1 Study to Determine Safety, Blood PK and Lung Penetration

NCT01034774

Phase 1 Completed 40 enrolled Achaogen, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2010-01
Primary completion
2010-06
Completion
2010-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator plazomicin Small molecule 15 mg/kg Intravenous

Indications

No indication recorded.