A Phase 1 interventional study of MP-376 (Levofloxacin solution for Inhalation) and placebo in Cystic Fibrosis, sponsored by Amgen. Completed at 14 sites in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Amgen · Phase 1, Interventional, and Treatment
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms and reduce the emergence of resistant bacteria.
This trial will be a single-blind, placebo-controlled, dose escalating between cohorts, single and multi-dose, multi-center study to evaluate the safety, tolerability and pharmacokinetic profile of levofloxacin administered as MP-376 once, then twice daily for 14 days by the aerosol route to CF patients.
Study acquired from Horizon in 2024.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 40 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Inhaled Levofloxacin
Drug: MP-376 (Levofloxacin solution for Inhalation)
Placebo
Drug: placebo
40, 80, 120mg RDD
BID
Safety and tolerability of MP-376 administered twice a day for 14 days
Time frame: 14 days
Evaluate changes in the microbiology of CF sputum after 14 days of treatment with MP-376
Time frame: 14 days
PK Profile of single-dose vs multi-dose of MP-376
Time frame: 14 days
Evaluate changes in FEV1 and FVC over 14 days of Treatment
Time frame: 14 days
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Amgen