Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01551316 | Safety Study to Evaluate MN-221 in Chronic Obstructive Pulmonary Disease (COPD) Patients | PHASE1 | COMPLETED | 19 | — | — | Mar 1, 2012 | May 1, 2012 | May 21, 2012 | 2 | United States |
| NCT01013142 | Evaluate the Safety of MN-221 in Subjects With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) | PHASE1 | COMPLETED | 48 | — | — | Nov 1, 2009 | Mar 1, 2010 | May 13, 2015 | 7 | United States |
The recording of AEs will start after the subject has signed the consent form and will end at the Hour 24 phone interview. Investigator(s) will monitor each subject closely for AEs and the Investigator will record all observed or volunteered AEs.
| Arm | Type | Description |
|---|---|---|
| MN-221 | EXPERIMENTAL | If the participants qualify, they will be randomized into one of two arms for 4 days. The arms are either Placebo (no medication) or MN-221 intravenously infused. |
| PLACEBO | EXPERIMENTAL | If the participants qualify, they will be randomized into one of two arms for 4 days. The arms are either Placebo (no medication) or MN-221 intravenously infused. |
| MN-221 Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MN-221 | DRUG | This drug is intravenously infused and delivers 1200 mcg to the patient in 1 hour duration. This dose is repeated over 4 days (Day 1 1200 mcg once; Day 2 1200 mcg twice; Day 3 1200 mcg twice; Day 4 1200 mcg once). |
| Placebo | DRUG | This intervention consists of a placebo intravenous infusion, one that contains no active medication. During the double-blind procedure, patients will be infused with placebo intravenously one time on Day 1, twice on Days 2 and 3, and one time on Day 4. |
| MN-221 (Dose Group 1) | DRUG | i.v. infusion of MN-221 (300 mcg) or placebo over 1 hour |
| MN-221 (Dose Group 2) | DRUG | i.v. infusion of MN-221 (600 mcg) or placebo over 1 hour |
| MN-221 (Dose Group 3) | DRUG | i.v. infusion of MN-221 (1,200 mcg) or placebo over 1 hour |
Inclusion Criteria: * Male or female 40-75 years of age, inclusive; * History of physician-diagnosed (e.g., by clinical history, \>15-pack year history of smoking, physical examination, and spirometry) COPD treated for ≥ 3 months prior to Visit 1 Pre-Screening; * FEV1 ≥ 30% and \< 80% predicted and...