drugset / Trial / NCT02459158

A Study to Assess the Pharmacokinetic Profile, the Safety, and the Tolerability of ME1100 Inhalation Solution in Patients With Mechanically Ventilated Bacterial Pneumonia

NCT02459158 ↗

Phase 1 Completed 25 enrolled Meiji Seika Pharma Co., Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is a randomized, open-label phase I study. The primary objective of this study is to assess the pharmacokinetic (PK) profile of ME1100 in subjects with mechanically ventilated bacterial pneumonia (MVBP). The secondary objective of this study is to assess the safety and tolerability of ME1100 for the treatment of subjects with MVBP to assess the safety and tolerability of ME1100.

Timeline

Start
2015-09
Primary completion
2017-03-22
Completion
2017-03-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Arbekacin Unknown — Inhaled

Indications