Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
This study will be a Phase 1b, multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of MP-376 solution for inhalation given for 5 days to COPD patients.
Study acquired from Horizon in 2024.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\>/= 40 years of age
History of COPD
FEV1 \</= 65% of predicted and FEV1/FVC \</= 0.7 value at Screening
Clinically stable with no changes in health status within the last 30 days
Lifetime smoking history of at least 15 pack-years
Willing and able to give informed consent
You may not be if
Use of any systemic or inhaled antibiotics within 30 days prior to baseline
History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
CrCl \< 50/ml/min, AST, ALT or total bilirubin \>/= 3 x ULN at Screening
