NCT02459158

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

A Randomized, Open-Label Phase 1b Study of ME1100 Inhalation Solution Plus Best Available Therapy in the Treatment of Mechanically Ventilated Subjects With Bacterial Pneumonia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Meiji Seika Pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumonia, Bacterial

Interventions

Type	Name	Description
DRUG	ME1100 inhalation solution	Low dose of ME1100 inhalation solution twice daily for up to 14 days to be administered via eFlow nebulizer system
DRUG	ME1100 inhalation solution	High dose of ME1100 inhalation solution twice daily for up to 14 days to be administered via eFlow nebulizer system

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-03-22
• Completion: 2017-03-22
• First posted: 2015-06-01
• Last updated: 2017-07-05

Locations

14 sites across 1 country: United States