Evaluate the Safety of MN-221 in Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Inclusion Criteria:

1. Male or female 40-65 years of age, inclusive;
2. History of physician-diagnosed COPD treated for ≥ 3 months ;
3. FEV1 ≥ 30% < 80% and FEV1/FVC ratio < 0.7 at screening;
4. An increase in FEV1 of at least 12%, over the pre-albuterol FEV1 within 30 minutes after inhalation of albuterol;
5. 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);
6. Negative urine drug screen for cocaine, PCP, methamphetamine;
7. ECG with no evidence of ischemic heart disease or dysrhythmias and otherwise normal or with findings considered not clinically significant at screening;
8. QTcB and QTcF < 450 msec;
9. No clinical evidence of active ischemic heart disease as determined by the Investigator; and
10. Legally effective written informed consent obtained prior to starting any study procedures.

Exclusion Criteria:

1. Beta agonist and/or anticholinergic via inhaler or intravenously ≤ 6 hours of screening;
2. Sustained release methylxanthine (e.g. Theophylline) or long acting beta agonists ≤ 24 hours prior to screening;
3. A diagnosis of clinically significant myocardial or valvular disease; including cardiomyopathy, congestive heart failure, or pulmonary edema;
4. Acute exacerbation of COPD requiring emergency treatment ≤ 30 days of screening or hospitalization ≤ 90 days of screening;
5. Antibiotic therapy for respiratory infection ≤ 30 days of screening;
6. Presence of active respiratory disease such as pneumonia, or acute bronchitis;
7. History or presence of tachyarrhythmias, with the exception of sinus tachycardia;
8. Hypokalemia defined as a potassium level ≤ 3.0 mmol/L at screening;
9. Significant renal, hepatic, endocrine, metabolic, neurologic or other systemic disease;
10. Uncontrolled hypertension defined as a blood pressure ≥ 170/100 mm Hg at screening;
11. Pregnant or lactating females;
12. Participation in another clinical study with an investigational drug within 30 days of screening;
13. A known allergy to excipients of the MN-221 drug product;
14. A known allergy to other beta agonists;
15. Previous exposure to MN-221; or
16. Use of beta blockers, MAO inhibitors, or tricyclic antidepressants ≤ 2 weeks prior to screening.