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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this clinical study is to determine the safety of intravenous MN-221 compared to placebo when administered in subjects diagnosed with stable moderate to severe COPD.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MediciNova

Criteria

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.