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

Completed · Phase 1 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT01013142

Run by

MediciNova

People needed

48

Starts

2009-11-01

Expected to finish

2010-03-01

Last updated by the study team

2015-05-13

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Dedicated Phase I — Phoenix, Arizona, United States
• California Research Medical Group, INC — Fullerton, California, United States
• Vita Research Solutions & Medical Center, Inc. — Tamarac, Florida, United States
• Florida Pulmonary Research Institue, LLC — Winter Park, Florida, United States
• Vince and Associates Clinical Research — Overland Park, Kansas, United States
• Gulf Coast Research, LLC — Lafayette, Louisiana, United States
• SNBL CLinical Pharmacology Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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