Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MN-221 · 4 trials · 2 indications
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 |
|---|---|---|
| 1 | EXPERIMENTAL | MN-221 given i.v. 1-hour infusion a total dose of 1200 μg (40 μg/min for 15 min \[600 μg\] + 13.3 μg/min for 45 min \[600 μg\]) as an adjunct to the standard of care for acute exacerbation of asthma. |
| Placebo | PLACEBO_COMPARATOR | Placebo (Lot #CLO-095) was packaged in identical vials containing only excipients and administered as an i.v. 1-hour infusion with a regimen as described for MN-221. |
| MN-221 | EXPERIMENTAL | - |
| MN-221 Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MN-221 | DRUG | Dose: intravenous 1-hour infusion of MN-221 (total dose 1200 μg) or matching placebo. |
| Placebo | DRUG | - |
| 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: * Subjects meeting all of the following criteria will be considered for admission to the study: 1. Male or female 18 to 65 years of age, inclusive; 2. Self-reported history of physician-diagnosed and treated asthma for ≥ 3 months prior to randomization; 3. A diagnosis of ...
MN-221 is an investigational small molecule being studied for the treatment of respiratory conditions, specifically Chronic Obstructive Pulmonary Disease (COPD) and asthma. It has been evaluated in clinical trials for acute exacerbations of asthma and for stable moderate to severe COPD. The drug is not approved and remains in clinical development.
MN-221 is being developed by MediciNova, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol MNOV. The company has sponsored clinical trials evaluating the drug in patients with asthma and COPD in the United States.
MN-221 has completed Phase 2 clinical trials for asthma and Phase 1 trials for COPD. All four studies listed for the drug are completed, with no active trials currently enrolling. The drug is investigational and has not received FDA approval.
MN-221 has been studied in four completed clinical trials. Two Phase 2 trials in asthma include NCT00679263 with 17 patients and NCT00838591 with 176 patients. Two Phase 1 trials in COPD include NCT01013142 with 48 patients and NCT01551316 with 19 patients. All trials were conducted in the United States.
MN-221 is the sole name provided for this investigational drug in the clinical trial records. No alternative names or brand names have been associated with it in the available data. The drug is identified only as MN-221 in the completed trials for asthma and COPD.
MN-221 was evaluated in randomized, double-blind, placebo-controlled trials for asthma, with a total of 193 patients enrolled across the two Phase 2 studies. The trials did not use biomarker selection. The COPD trials were Phase 1 safety studies with 67 total patients.