Safety Study to Evaluate MN-221 in Chronic Obstructive Pulmonary Disease (COPD) Patients

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring safety, pharmacokinetics, spirometry Read More

Inclusion Criteria:

• Male or female 40-75 years of age, inclusive;
• History of physician-diagnosed (e.g., by clinical history, >15-pack year history of smoking, physical examination, and spirometry) COPD treated for ≥ 3 months prior to Visit 1 Pre-Screening;
• FEV1 ≥ 30% and < 80% predicted and FEV1/FVC ratio < 0.7 at Visit 1 Pre-Screening and Visit 2 Screening;
• Negative urine pregnancy test for all females unless the subject is post-menopausal (≥ 24 months of spontaneous amenorrhea) or surgically sterile (hysterectomy, bilateral ovariectomy or bilateral tubal ligation);
• Negative urine drug screen for cocaine, phencyclidine (PCP), methamphetamine;
• Negative alcohol breath test;
• Electrocardiogram (ECG) without serious abnormality and with QTcB and QTcF < 460 milliseconds (msec);
• Ability to wash-out of concomitant LABA and Theophylline, if ongoing, for 7-8 days (i.e., Visit 2 Screening through 5-Day Treatment Period).
• Legally effective written informed consent obtained prior to starting any study procedures.
• Subject willing and able to comply with the protocol and procedures, as judged by Investigator.

Exclusion Criteria:

• Sustained release methylxanthine (e.g. Theophylline) or long acting beta agonists ≤ 48 hours prior to treatment start (Day 1);
• Acute exacerbation of COPD requiring emergency treatment ≤ 30 days of screening or hospitalization ≤ 60 days of Visit 2 Screening;
• Antibiotic therapy for respiratory infection ≤ 15 days of Visit 2 Screening;
• Presence of active respiratory disease such as pneumonia and acute exacerbation of chronic bronchitis;
• Hypokalemia defined as a potassium level <3.0 mmol/L at Visit 2 Screening. note: Subjects <3.0 mmol/L may be re-screened at Visit 2 Screening after receiving potassium replacement therapy;
• Significant clinical laboratory abnormality that, in the opinion of the Investigator, may put the subject at risk;
• Significant renal, hepatic, endocrine, neurologic or other systemic disease that, in the opinion of the Investigator, may put the subject at undue risk;
• Uncontrolled hypertension (defined as a blood pressure ≥ 170/100 mm Hg at Visit 1 Pre-Screening) and/or uncontrolled angina, uncontrolled diabetes, uncontrolled congestive heart failure (CHF), uncontrolled serious arrhythmia;
• Myocardial infarction within 6 months of treatment start;
• Pregnant or lactating females;
• Participation in another clinical study with an investigational drug within 30 days of Visit 1 Pre-Screening;
• Patients with home oxygen requirements.
• A known allergy to excipients of the MN-221 drug product;
• A known allergy to other beta agonists;
• Currently on medication/s that are recognized to have risk of Torsades de Pointes