Study Evaluating the Safety and Effects of MN-221 in Subjects With Moderate to Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      This is a multi-center, randomized, single-blind*, parallel group, placebo-controlled, study
      with two dosing regimens in subjects diagnosed with moderate to severe asthma using MN-221 or
      placebo. Subjects will be randomized to receive MN-221 or placebo in a 3:1 ratio,
      MN-221:placebo. Subjects randomized to receive MN-221 will be dosed with active study drug at
      both dosing visits, and subjects randomized to the placebo arm will receive placebo at both
      dosing visits. Approximately 25 subjects diagnosed with moderate to severe asthma who have
      not received inhaled corticosteroid therapy within one month of Screen Visit 1 will be
      enrolled and will participate throughout the study.

      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 MN-221 or Placebo)

      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 MN-221 or Placebo)

      There will be approximately a two to four week period between each dose regimen, during which
      time a safety review will be performed before proceeding to the next dose level. Subjects
      will be screened for eligibility and continued eligibility will be determined for each
      subject prior to administering each dose. After the initiation of the intravenous infusion of
      MN-221 or placebo, serial spirometry will be measured for approximately 24 hours.

      For each dose evaluation period, subjects will be domiciled in the clinical research unit
      (CRU) for 2 nights, beginning on Day -1, one day before dosing. Determination of continued
      study eligibility will be made on Day -1 for each dose level. Day 1 will include study drug
      infusion and approximately a 24-hour observation period into Day 2 to allow safety
      monitoring, serial spirometry, and serum PK measurements. Subjects will be discharged from
      the CRU on Day 2. They will return to the CRU approximately 2-4 weeks later to participate in
      the subsequent dose group.

      *This is a "modified" single-blind study in which the subject and Investigator are both
      blinded regarding the treatment arm.
    

Intervention name(s): MN-221; MN-221; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: asthma; randomized; placebo controlled; dose escalation; safety; efficacy; single blind; MN-221