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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.
This is a randomized, double-blind, placebo-controlled, multi-center dose escalation study in subjects diagnosed with stable moderate to severe COPD. The study will be conducted in approximately 6 Clinical Research Units (CRUs).
Subjects with a diagnosis of stable moderate to severe COPD will be screened and must demonstrate an improvement in FEV1 after bronchodilator treatment of at least 12% at Screen Visit 1. The subject's degree of dyspnea will be captured on the British Medical Research Council (MRC) questionnaire, and severity will be determined by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) spirometric criteria. Subjects meeting entry criteria at Screen Visit 1 will be asked to return to the CRU for Screen Visit 2 within 14 days of Visit 1. Subjects confirming entry criteria including degree of COPD severity by spirometry at Screen Visit 2 will be randomized to receive either MN-221 or placebo. Serial spirometry will be performed over the 8 hour treatment period after initiation of study drug administration. Subjects will be discharged from the CRU after completing the Hour 8 study procedures and asked to return approximately 24 hours after initiation of study drug for follow up safety assessments including spirometry. A study diary will be provided to each subject upon discharge from the CRU to complete as instructed and return it to the site at the 24 hour Follow-up Visit.
There will be three dose levels and each will include approximately 16 subjects randomized to receive either MN-221 or placebo in 3:1 ratio (12 subjects receive MN-221:4 subjects receive placebo). A risk/benefit evaluation will be performed by the study's Safety Review Committee at completion of each dose level prior to escalating to the next dose level.
Safety and efficacy will be monitored throughout the treatment period. Blood samples for PK parameters and metabolite identification will be obtained.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
MN-221 (Dose Group 1), MN-221 (Dose Group 2), MN-221 (Dose Group 3)
Dedicated Phase I
Published on BioPortfolio: 2014-07-23T21:11:48-0400
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COPD (chronic obstructive pulmonary disease)
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