Study Evaluating the Safety and Effects of MN-221 in Subjects With Moderate to Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: MN-221; MN-221; Placebo
Intervention description: Initial dose: 16 μg/min for 15 minutes followed by 8 μg/min for 105 minutes (2-hour infusion with a total dose of 1,080 μg); Subsequent dose: 30 μg/min for 15 minutes followed by 15 μg/min for 45 minutes (1-hr infusion with a total dose of 1,125 μg).; Placebo intravenous infusion with dosing volume equivalent to active treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: asthma; randomized; placebo controlled; dose escalation; safety; efficacy; single blind; MN-221

Summary:

      The purpose of this study is to evaluate the safety and tolerability of MN-221 at two
      different dosing rates administered through a continuous infusion in subjects diagnosed with
      moderate to severe asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects;

          2. Must sign an informed consent;

          3. Diagnosis of asthma as defined by the American Thoracic Society for at least 3 months;

          4. Must not be receiving inhaled corticosteroids for control within 1 month of study;

          5. Must have an increase in FEV1 of at least 12% and 200 cc over the pre-albuterol FEV1
             within 30 minutes after inhalation of up to 4 puffs of albuterol via a metered dose
             inhaler;

          6. Non-smoker for at least 6 months and in good health;

          7. Female subjects must have a negative pregnancy test;

          8. Male and female subjects of child-bearing potential (not surgically sterile or post
             menopausal) must be abstinent or agree to use contraceptive regimens throughout the
             study;

          9. Subjects receiving allergy desensitization therapy can participate as long as they
             have been on a stable maintenance dose for ≥ 6 months;

         10. Subject must be willing and able not to use inhaled bronchodilators for 6 hours before
             and until 24 hours after each study drug administration at all study visits; and

         11. Subject must demonstrate mental and physical ability and willingness to follow all
             study-specific instructions pertaining to the scheduling of study visits and
             assessments.

        Exclusion Criteria:

          1. Have significant cardiopulmonary, renal, hepatic, endocrine, metabolic, neurological
             or other systemic disease;

          2. Received emergency treatment for asthma within 1 month, or hospitalized for asthma
             within 3 months;

          3. Had an upper or lower respiratory tract infection within 3 weeks, or sinus infection
             within 7 days;

          4. Have participated in a clinical study with an investigational drug, other than an
             MN-221 study, within 30 days;

          5. Have history or evidence of drug or alcohol abuse within 2 years of study entry;

          6. Female subjects who are pregnant or lactating;

          7. Taking any of the following excluded asthma/allergy medications within the time
             periods indicated prior to the first study visit:

               -  Oral, inhaled, or parenteral corticosteroids for 1 month prior to the first study
                  visit.

               -  Anti-IgE medication for 3 months prior to the first study visit.

               -  Theophylline, long-acting bronchodilators, and anti-cholinergics for 2 weeks
                  prior to the first study visit.

          8. Taking leukotriene modifiers and not on a stable daily dosage for 4 weeks prior to the
             first study visit.

          9. Taking antihistamines, nasal corticosteroids, or decongestants and not on a stable
             dose for 3 days prior to any dosing day.

         10. Have a known allergy to MN-221 or any of the other components of the study drug (i.e.
             lactose);

         11. Have a history of frequent episodes of orthostatic hypotension or any predisposition
             for orthostatic hypotension;

         12. Have used any prescription or over-the-counter medication, vitamin or herbal
             supplement (except as listed in Inclusion Criterion 7 and Exclusion Criterion 7-10)
             within 7 days of study entry, or the expected need to use any unapproved prescription
             or over-the-counter medication or supplement seven days prior to the first study visit
             until completion of the study;

         13. Taking any drugs or substances known to be strong inhibitors of cytochrome P450
             enzymes within 10 days of study entry, or the expected need to use such drugs ten days
             prior to the first study visit until after completion of the study;

         14. Taking any drugs or substances known to be strong inducers of cytochrome P450 enzymes
             within 28 days of study entry, or the expected need to use such drugs prior to
             completion of the study;

         15. Adhering to any special diet that is not well balanced within 28 days of study entry;

         16. Have donated (standard donation amount or more) blood or blood products (with the
             exception of plasma noted below) within 56 days of study entry;

         17. Have donated plasma within 7 days of study entry;

         18. Have any laboratory value outside the laboratory reference range that is considered to
             be clinically significant;

         19. Have any abnormal vital signs (B/P, respiratory rate, heart rate) considered to be
             clinically significant;

         20. Have positive results for drug and/or alcohol screen;

         21. Have any clinically significant ECG abnormality, including a corrected QT interval
             (QTc) > 450 msec; and/or

         22. Have any other medical condition or reason that, in the Investigator's opinion, makes
             the subject unsuitable to participate in this clinical trial.