Evaluate the Safety of MN-221 in Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase I Randomized, Double-blind, Placebo-controlled Dose Escalation Study to Evaluate the Safety and Efficacy of MN-221 When Administered Intravenously to Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
48
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 chronic-obstructive-pulmonary-disease
Started Nov 2009
Shorter than P25 for phase_1 chronic-obstructive-pulmonary-disease
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 10, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedMay 13, 2015
May 1, 2015
4 months
November 10, 2009
May 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events, cardiac and ECG parameters, vital signs, physical exam and clinical laboratory assessments.
Hour 0 (treatment) through Hour 24 (follow-up)
Secondary Outcomes (2)
Pharmacokinetic parameters of MN-221.
Pre-dose to Hour 24 post-dose
Forced expiratory volume in one second (FEV1).
Pre-dose to Hour 24 post-dose
Study Arms (2)
MN-221
EXPERIMENTALMN-221 Placebo
PLACEBO COMPARATORInterventions
i.v. infusion of MN-221 (300 mcg) or placebo over 1 hour
i.v. infusion of MN-221 (600 mcg) or placebo over 1 hour
i.v. infusion of MN-221 (1,200 mcg) or placebo over 1 hour
Eligibility Criteria
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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MediciNovalead
Study Sites (7)
Dedicated Phase I
Phoenix, Arizona, 85013, United States
California Research Medical Group, INC
Fullerton, California, 92835, United States
Vita Research Solutions & Medical Center, Inc.
Tamarac, Florida, 33319, United States
Florida Pulmonary Research Institue, LLC
Winter Park, Florida, 32789, United States
Vince and Associates Clinical Research
Overland Park, Kansas, 66211, United States
Gulf Coast Research, LLC
Lafayette, Louisiana, 70503, United States
SNBL CLinical Pharmacology Center
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alan W Dunton, MD
MediciNova
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2009
First Posted
November 13, 2009
Study Start
November 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
May 13, 2015
Record last verified: 2015-05